Trial Outcomes & Findings for Study of Ociperlimab (BGB-A1217) in Combination With Tislelizumab in Advanced Solid Tumors (NCT NCT04047862)
NCT ID: NCT04047862
Last Updated: 2025-08-22
Results Overview
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. A serious adverse event (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. Treatment-emergent adverse event (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 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
Target enrollment
446 participants
Primary outcome timeframe
Up to 30 days after the last dose of study interventions (up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts])
Results posted on
2025-08-22
Participant Flow
Participant milestones
| Measure |
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
Participants received ociperlimab 50 milligrams (mg) intravenous (IV) infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (that is, \[i.e.\], every 3 weeks \[Q3W\]) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 1
Participants with metastatic squamous non-small cell lung cancer (NSCLC) received treatment with ociperlimab 900 mg IV infusion along with tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle. Participants also received 4 to 6 cycles of chemotherapy with carboplatin area under the curve (AUC) 5 or 6 (Day 1) + paclitaxel 200 or 175 mg/m\^2 (Day 1) or nab paclitaxel 100 mg/m\^2 (Days 1, 8 and 15) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 2
Participants with metastatic non-squamous NSCLC received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle. Participants also received cisplatin 75 mg/m\^2 or carboplatin (AUC 5) and pemetrexed 500 mg/m\^2 (on Day 1) Q3W for 4-6 cycles followed by ociperlimab 900 mg + tislelizumab 200 mg + pemetrexed 500 mg/m\^2 on Day 1 Q3W and were followed up until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 3
Participants with metastatic NSCLC (programmed cell death protein-ligand 1 \[PD-L1\] positive, tumour cells \[TC\] \>=1%) were treated with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 4
Participants with extensive-stage small-cell lung cancer (SCLC) received treatment with ociperlimab 900 mg IV infusion, tislelizumab 200 mg IV infusion. Participants also received 4 cycles of etoposide 100 mg/m\^2 (on Days 1, 2, 3), and cisplatin 75 mg/m\^2 /carboplatin AUC 5 (Day 1) Q3W, followed by ociperlimab 900 mg (Day 1) + tislelizumab 200 mg (Day 1) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 5
Checkpoint inhibitor (CPI)-experienced NSCLC participants received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of each 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 6
Participants with metastatic esophageal squamous cell carcinoma (ESCC) received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, cisplatin 75 mg/m\^2 (Day 1), and Fluorouracil 750-800 mg/m\^2 (5-FU; Day 1 to Day 5) or paclitaxel 200 or 175 mg/m\^2 (Day 1) Q3W followed by ociperlimab 900 mg and tislelizumab 200 mg on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 7
Participants with metastatic esophageal adenocarcinoma (EAC) received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, cisplatin 75 mg/m\^2 (Day 1), and Fluorouracil 750-800 mg/m\^2 (5-FU; Day 1 to Day 5) or paclitaxel 200 or 175 mg/m\^2 (Day 1) Q3W followed by ociperlimab 900 mg and tislelizumab 200 mg on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
Participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC; PD-L1 positive, visually estimated Combined Positive Score \[vCPS\] \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
Participants with unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Overall Study
STARTED
|
1
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3
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6
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16
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6
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9
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11
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41
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43
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45
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43
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26
|
21
|
6
|
41
|
60
|
24
|
21
|
23
|
|
Overall Study
COMPLETED
|
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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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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3
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6
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16
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6
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9
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11
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41
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43
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45
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43
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26
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21
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6
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41
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60
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24
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21
|
23
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Reasons for withdrawal
| Measure |
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
Participants received ociperlimab 50 milligrams (mg) intravenous (IV) infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (that is, \[i.e.\], every 3 weeks \[Q3W\]) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 1
Participants with metastatic squamous non-small cell lung cancer (NSCLC) received treatment with ociperlimab 900 mg IV infusion along with tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle. Participants also received 4 to 6 cycles of chemotherapy with carboplatin area under the curve (AUC) 5 or 6 (Day 1) + paclitaxel 200 or 175 mg/m\^2 (Day 1) or nab paclitaxel 100 mg/m\^2 (Days 1, 8 and 15) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 2
Participants with metastatic non-squamous NSCLC received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle. Participants also received cisplatin 75 mg/m\^2 or carboplatin (AUC 5) and pemetrexed 500 mg/m\^2 (on Day 1) Q3W for 4-6 cycles followed by ociperlimab 900 mg + tislelizumab 200 mg + pemetrexed 500 mg/m\^2 on Day 1 Q3W and were followed up until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 3
Participants with metastatic NSCLC (programmed cell death protein-ligand 1 \[PD-L1\] positive, tumour cells \[TC\] \>=1%) were treated with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 4
Participants with extensive-stage small-cell lung cancer (SCLC) received treatment with ociperlimab 900 mg IV infusion, tislelizumab 200 mg IV infusion. Participants also received 4 cycles of etoposide 100 mg/m\^2 (on Days 1, 2, 3), and cisplatin 75 mg/m\^2 /carboplatin AUC 5 (Day 1) Q3W, followed by ociperlimab 900 mg (Day 1) + tislelizumab 200 mg (Day 1) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 5
Checkpoint inhibitor (CPI)-experienced NSCLC participants received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of each 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 6
Participants with metastatic esophageal squamous cell carcinoma (ESCC) received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, cisplatin 75 mg/m\^2 (Day 1), and Fluorouracil 750-800 mg/m\^2 (5-FU; Day 1 to Day 5) or paclitaxel 200 or 175 mg/m\^2 (Day 1) Q3W followed by ociperlimab 900 mg and tislelizumab 200 mg on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 7
Participants with metastatic esophageal adenocarcinoma (EAC) received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, cisplatin 75 mg/m\^2 (Day 1), and Fluorouracil 750-800 mg/m\^2 (5-FU; Day 1 to Day 5) or paclitaxel 200 or 175 mg/m\^2 (Day 1) Q3W followed by ociperlimab 900 mg and tislelizumab 200 mg on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
Participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC; PD-L1 positive, visually estimated Combined Positive Score \[vCPS\] \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
Participants with unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
4
|
7
|
2
|
4
|
3
|
24
|
24
|
22
|
35
|
18
|
14
|
6
|
19
|
42
|
9
|
8
|
10
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
5
|
2
|
0
|
1
|
0
|
4
|
4
|
4
|
2
|
3
|
0
|
9
|
5
|
1
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
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0
|
0
|
0
|
1
|
0
|
1
|
0
|
3
|
0
|
0
|
2
|
2
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Completed all Assessments
|
1
|
3
|
1
|
3
|
2
|
5
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Sponsor Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
13
|
10
|
18
|
3
|
3
|
4
|
0
|
7
|
8
|
9
|
7
|
8
|
|
Overall Study
Transfer to a Company Sponsored Clinical Trial
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
5
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
2
|
2
|
2
|
|
Overall Study
Transfer to Patient Supply Treatment Program (PTS)
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
1
|
1
|
0
|
Baseline Characteristics
Study of Ociperlimab (BGB-A1217) in Combination With Tislelizumab in Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
n=1 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=3 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=6 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=16 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=6 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
n=9 Participants
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=11 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 1
n=41 Participants
Participants with metastatic squamous NSCLC received treatment with ociperlimab 900 mg IV infusion along with tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle. Participants also received 4 to 6 cycles of chemo with carboplatin AUC 5 or 6 (Day 1) + paclitaxel 200 or 175 mg/m\^2 (Day 1) or nab paclitaxel 100 mg/m\^2 (Days 1, 8 and 15) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 2
n=43 Participants
Participants with metastatic non-squamous NSCLC received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle. Participants also received cisplatin 75 mg/m\^2 or carboplatin (AUC 5) and pemetrexed 500 mg/m\^2 (on Day 1) Q3W for 4-6 cycles followed by ociperlimab 900 mg + tislelizumab 200 mg + pemetrexed 500 mg/m\^2 on Day 1 Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 3
n=45 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>=1%) were treated with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 4
n=43 Participants
Participants with extensive-stage SCLC received treatment with ociperlimab 900 mg IV infusion, tislelizumab 200 mg IV infusion. Participants also received 4 cycles of etoposide 100 mg/m\^2 (on Days 1, 2, 3), and cisplatin 75 mg/m\^2 /carboplatin AUC 5 (Day 1) Q3W, followed by ociperlimab 900 mg (Day 1) + tislelizumab 200 mg (Day 1) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 5
n=26 Participants
Checkpoint inhibitor (CPI)-experienced NSCLC participants received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of each 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 6
n=21 Participants
Participants with metastatic ESCC received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, cisplatin 75 mg/m\^2 (Day 1), and Fluorouracil 750-800 mg/m\^2 (5-FU; Day 1 to Day 5) or paclitaxel 200 or 175 mg/m\^2 (Day 1) Q3W followed by ociperlimab 900 mg and tislelizumab 200 mg on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Expansion: Cohort 7
n=6 Participants
Participants with metastatic EAC received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, cisplatin 75 mg/m\^2 (Day 1), and Fluorouracil 750-800 mg/m\^2 (5-FU; Day 1 to Day 5) or paclitaxel 200 or 175 mg/m\^2 (Day 1) Q3W followed by ociperlimab 900 mg and tislelizumab 200 mg on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
n=41 Participants
Participants with recurrent or metastatic HNSCC; PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
n=60 Participants
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
n=24 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=21 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
n=23 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Total
n=446 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.0 years
STANDARD_DEVIATION NA • n=5 Participants
|
48.7 years
STANDARD_DEVIATION 18.90 • n=7 Participants
|
56.8 years
STANDARD_DEVIATION 11.25 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 14.75 • n=4 Participants
|
67.0 years
STANDARD_DEVIATION 6.90 • n=21 Participants
|
61.9 years
STANDARD_DEVIATION 7.66 • n=8 Participants
|
60.4 years
STANDARD_DEVIATION 11.45 • n=8 Participants
|
64.9 years
STANDARD_DEVIATION 8.04 • n=24 Participants
|
62.7 years
STANDARD_DEVIATION 8.71 • n=42 Participants
|
65.4 years
STANDARD_DEVIATION 8.59 • n=42 Participants
|
63.6 years
STANDARD_DEVIATION 9.79 • n=42 Participants
|
66.7 years
STANDARD_DEVIATION 9.34 • n=42 Participants
|
62.2 years
STANDARD_DEVIATION 6.02 • n=36 Participants
|
63.0 years
STANDARD_DEVIATION 4.24 • n=36 Participants
|
63.5 years
STANDARD_DEVIATION 10.74 • n=24 Participants
|
60.1 years
STANDARD_DEVIATION 11.65 • n=135 Participants
|
61.5 years
STANDARD_DEVIATION 10.46 • n=136 Participants
|
64.0 years
STANDARD_DEVIATION 7.05 • n=44 Participants
|
65.4 years
STANDARD_DEVIATION 8.98 • n=667 Participants
|
62.8 years
STANDARD_DEVIATION 10.03 • n=12 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
6 Participants
n=24 Participants
|
16 Participants
n=135 Participants
|
7 Participants
n=136 Participants
|
4 Participants
n=44 Participants
|
6 Participants
n=667 Participants
|
116 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
35 Participants
n=24 Participants
|
31 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
32 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
18 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
35 Participants
n=24 Participants
|
44 Participants
n=135 Participants
|
17 Participants
n=136 Participants
|
17 Participants
n=44 Participants
|
17 Participants
n=667 Participants
|
330 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
4 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
41 Participants
n=24 Participants
|
43 Participants
n=42 Participants
|
44 Participants
n=42 Participants
|
43 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
21 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
41 Participants
n=24 Participants
|
58 Participants
n=135 Participants
|
24 Participants
n=136 Participants
|
20 Participants
n=44 Participants
|
22 Participants
n=667 Participants
|
441 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
1 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
38 Participants
n=24 Participants
|
35 Participants
n=42 Participants
|
34 Participants
n=42 Participants
|
32 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
16 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
37 Participants
n=24 Participants
|
46 Participants
n=135 Participants
|
22 Participants
n=136 Participants
|
19 Participants
n=44 Participants
|
17 Participants
n=667 Participants
|
333 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
1 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
11 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
6 Participants
n=667 Participants
|
95 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
3 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Not Reported/Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
4 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
9 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
1 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after the last dose of study interventions (up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts])Population: Analysis was performed on the safety analysis set that included all participants who received \>= 1 dose of any study drug.
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. A serious adverse event (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. Treatment-emergent adverse event (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 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: Ociperlimab 50 mg + Tislelizumab 200 mg
n=1 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=3 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=6 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=16 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=6 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
n=9 Participants
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=11 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Participants with any TEAE
|
1 Participants
|
3 Participants
|
6 Participants
|
15 Participants
|
6 Participants
|
9 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Participants with >= Grade 3 TEAE
|
1 Participants
|
2 Participants
|
4 Participants
|
11 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Serious TEAE
|
1 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 28 days (for Dose escalation cohorts) and up to 21 days (for Dose verification cohorts)Population: Analysis was performed on the safety analysis set.
The DLTs were defined as high grade (Grade 3 or 4) non-hematologic toxicities (that is, \>= Grade 4 toxicity; Grade 3 toxicity that is clinically significant and does not resolve to baseline or \<=Grade 1 within 7 days of initiating optimal supportive care), or hematologic toxicities (Grade 4 neutropenia lasting \> 7 days; \>=Grade 3 febrile neutropenia; Grade 3 thrombocytopenia with clinically significant bleeding; Grade 4 thrombocytopenia lasting \> 7 days; \>=Grade 4 anemia occurring during the DLT assessment window and considered by the investigator to be related to ociperlimab and/or tislelizumab.
Outcome measures
| Measure |
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
n=1 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=3 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=6 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=16 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=6 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
n=9 Participants
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=11 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 28 days (Dose escalation cohort)Population: Analysis was performed on the safety analysis set.
MAD was defined as the highest dose of ociperlimab administered.
Outcome measures
| Measure |
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
n=32 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Maximum Administered Dose (MAD) of Ociperlimab in Combination With Tislelizumab
|
1800 milligram (mg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: up to 28 days (Dose escalation cohorts)Population: Analysis was performed on the safety analysis set.
RP2D of Ociperlimab in combination with Tislelizumab 200 mg was determined primarily from the safety, tolerability, and pharmacokinetic (PK) data of dose escalation cohorts.
Outcome measures
| Measure |
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
n=32 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Recommended Phase 2 Dose (RP2D) of Ociperlimab in Combination With Tislelizumab
|
900 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)Population: Analysis was performed on efficacy evaluable analysis set that included all treated participants who had measurable disease at baseline and \>= 1 evaluable postbaseline tumor response assessment unless discontinued from any component of study treatment due to clinical progression of disease (PD) or death within 7 weeks after first dose.
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: Ociperlimab 50 mg + Tislelizumab 200 mg
n=40 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=42 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=45 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=41 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=26 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
n=19 Participants
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=6 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
n=39 Participants
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
n=59 Participants
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
n=23 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=19 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
n=23 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
|
55 percentage of participants
Interval 38.5 to 70.7
|
54.8 percentage of participants
Interval 38.7 to 70.2
|
40.0 percentage of participants
Interval 25.7 to 55.7
|
65.9 percentage of participants
Interval 49.4 to 79.9
|
7.7 percentage of participants
Interval 0.9 to 25.1
|
68.4 percentage of participants
Interval 43.4 to 87.4
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
33.3 percentage of participants
Interval 19.1 to 50.2
|
50.8 percentage of participants
Interval 37.5 to 64.1
|
34.8 percentage of participants
Interval 16.4 to 57.3
|
26.3 percentage of participants
Interval 9.1 to 51.2
|
34.8 percentage of participants
Interval 16.4 to 57.3
|
SECONDARY outcome
Timeframe: Maximum time duration on study: up to 35.7 months (Dose escalation cohorts) and up to 13.3 months (Dose verification cohorts)Population: Analysis was performed on efficacy evaluable analysis set.
ORR was defined as the percentage of participants who had CR or PR as determined from investigator-derived tumor assessments per RECIST v. 1.1. 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: Ociperlimab 50 mg + Tislelizumab 200 mg
n=1 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=3 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=6 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=16 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=5 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
n=9 Participants
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=10 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: ORR as Per RECIST v.1.1
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
6.3 percentage of participants
Interval 0.2 to 30.2
|
20 percentage of participants
Interval 0.5 to 71.6
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
10 percentage of participants
Interval 0.3 to 44.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts])Population: Analysis was performed on participants in the efficacy evaluable analysis set with an objective response. Here, "0" in the overall number of participants analyzed signifies no participants with available data at the specified time-points.
DOR was defined as the time from the first determination of an overall response per RECIST v1.1 until the first documentation of progression (PD) 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: Ociperlimab 50 mg + Tislelizumab 200 mg
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=1 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=1 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=1 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=1 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Duration of Response (DOR) as Per RECIST v.1.1
|
—
|
—
|
2.8 months
95% Confidence Interval (CI) could not be calculated due to an insufficient number of participants with events.
|
3.6 months
95% CI could not be calculated due to an insufficient number of participants with events.
|
8.4 months
95% CI could not be calculated due to an insufficient number of participants with events.
|
—
|
7 months
95% CI could not be calculated due to an insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts])Population: Analysis was performed on efficacy evaluable analysis set.
DCR was defined as the percentage of participants with best overall response (BOR), as per RECIST v.1.1, of a CR, PR, or stable disease (SD). 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. Stable Disease (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: Ociperlimab 50 mg + Tislelizumab 200 mg
n=1 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=3 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=6 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=16 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=5 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
n=9 Participants
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=10 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Disease Control Rate (DCR) as Per RECIST v.1.1
|
0 percentage of participants
Interval 0.0 to 97.5
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
50 percentage of participants
Interval 11.8 to 88.2
|
50 percentage of participants
Interval 24.7 to 75.3
|
40 percentage of participants
Interval 5.3 to 85.3
|
33.3 percentage of participants
Interval 7.5 to 70.1
|
50 percentage of participants
Interval 18.7 to 81.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: C1D1 (pre and post dose; 24 hours (h) 72h, 168h and 336 h post-dose), C2D1 (pre- and post-dose), C5D1 (pre and post dose,168h and 336 h post-dose), C6D1 (pre and post-dose), pre-dose on C9D1,C13D1,C17D1,C25D1 (Cycle 1= 28 days; Cycle 2 onwards= 21 days)Population: Analysis was performed on the pharmacokinetic (PK) analysis set that included all participants who received \>= 1 dose of any component of study drugs per the protocol, and for whom any corresponding post-dose PK data were available. Here, number analyzed' = participants with available data of serum concentrations and "0" in the number analyzed signifies no participants with available data at specified time-points.
Serum concentrations of ociperlimab were measured. Post-dose refers to the data collected for 30 minutes post-infusion. "C" in the timeframe below refers to "Cycle" and D refers to "Day" and "h" refers to "hours".
Outcome measures
| Measure |
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
n=1 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=3 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=6 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=16 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=6 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Cycle 25 Day 1- Pre-dose
|
—
|
9.05 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with events.
|
47.20 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Cycle 1 Day 1- Pre-dose
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and Geometric coefficient of variation (GCV) could not be calculated due to an insufficient number of participants with lower limit of quantification (LLOQ) for analysis.
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Cycle 1 Day 1 post-dose
|
14.70 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with events.
|
44.59 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 32
|
130.22 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 19
|
259.66 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 21
|
525.97 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Cycle 1 Day 1- 24 h
|
10.30 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with events.
|
31.67 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 16
|
98.28 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 16
|
198.72 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 14
|
374.44 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Cycle 1 Day 1- 72 h
|
6.49 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with events.
|
18.43 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 20
|
64.36 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 29
|
136.15 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 12
|
256.28 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 35
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Cycle 1 Day 1- 168 h
|
2.58 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with events.
|
11.49 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 13
|
41.16 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 43
|
90.08 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 23
|
150.95 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Cycle 1 Day 1- 336 h
|
1.34 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with events.
|
7.03 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 28
|
29.30 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 46
|
64.72 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 21
|
101.42 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 40
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Cycle 2 Day 1- Pre-dose
|
0.33 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with events.
|
2.23 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 42
|
8.71 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 109
|
24.96 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 71
|
23.85 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 87
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Cycle 2 Day 1- Post-dose
|
13.90 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with events.
|
48.11 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 39
|
145.89 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 30
|
277.69 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 20
|
460.48 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 45
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Cycle 5 Day 1- Pre-dose
|
—
|
5.44 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with events.
|
28.39 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 45
|
46.15 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 108
|
121.94 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Cycle 5 Day 1- post-dose
|
—
|
35.60 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with events.
|
156.97 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 3
|
298.93 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 19
|
589.07 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 19
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Cycle 5 Day 1- 168 h
|
—
|
15.30 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with events.
|
77.59 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 14
|
140.04 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 35
|
265.52 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Cycle 5 Day 1- 336 h
|
—
|
8.38 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with events.
|
55.27 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 8
|
96.09 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 54
|
179.05 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Cycle 6 Day 1- Pre-dose
|
—
|
6.94 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with events.
|
23.92 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 102
|
66.59 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 64
|
154.07 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Cycle 6 Day 1- post-dose
|
—
|
40.40 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with events.
|
150.44 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 19
|
343.48 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 23
|
726.95 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Cycle 9 Day 1- Pre-dose
|
—
|
7.57 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with events.
|
36.98 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 20
|
49.92 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 41
|
140.64 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 10
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Cycle 13 Day 1- Pre-dose
|
—
|
8.12 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with events.
|
44.80 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with events.
|
66.70 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with events.
|
80.56 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 111
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Cycle 17 Day1- Pre-dose
|
—
|
—
|
45.50 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with events.
|
—
|
113.00 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 0.0000
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 8 (pre-dose), Cycle 1, Day 8 (post-dose), Cycle 2, Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose), Cycle 5 Day 1 (post-dose), pre-dose of Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 25 Day 1 (each cycle = 21 days)Population: Analysis was performed on PK analysis set. Here, number analyzed' = participants with available data for the analysis of serum concentrations and "0" in the number analyzed signifies no participant were available for analysis at specified time-points.
Serum Concentrations of Tislelizumab was determined. Post-dose refers to the data collected for 30 minutes post-infusion.
Outcome measures
| Measure |
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
n=1 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=3 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=6 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=16 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=6 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab
Cycle 1 Day 8 Predose
|
0.45 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
16.50 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
14.46 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 350
|
18.60 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 528
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab
Cycle 1 Day 8 Post-dose
|
54.60 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
62.89 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 38
|
82.34 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 48
|
67.93 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 46
|
60.28 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab
Cycle 2 Day 1 Predose
|
11.50 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
14.17 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 69
|
20.05 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 93
|
18.61 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 82
|
10.37 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 72
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab
Cycle 5 Day 1 Predose
|
—
|
17.50 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
30.79 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 32
|
21.91 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 109
|
33.64 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab
Cycle 5 Day 1 Postdose
|
—
|
63.40 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
102.03 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 5
|
76.71 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 29
|
98.97 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 21
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab
Cycle 6 Day 1 Predose
|
—
|
27.60 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
24.08 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 38
|
29.22 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 74
|
40.73 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab
Cycle 9 Day 1 Predose
|
—
|
29.10 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
36.28 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 34
|
30.73 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 34
|
37.67 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab
Cycle 13 Day 1 Predose
|
—
|
27.60 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
36.70 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
33.60 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
25.02 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 39
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab
Cycle 17 Day 1 Predose
|
—
|
—
|
43.00 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
—
|
26.79 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab
Cycle 25 Day 1 Predose
|
—
|
31.60 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
56.20 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, post-dose, 24 h,72 h,168 h,336 h post-dose C1D1, Pre-dose, post-dose on C2D1, Pre-dose, post-dose,168 h, 336 h post-dose on C5D1, Pre-dose, post-dose on C6D1, pre-dose C9D1 and C13D1 (each cycle = 21 days)Population: Analysis was performed on PK Analysis set. Here, number analyzed' = participants with available data for the analysis of serum concentrations.
Serum concentration of ociperlimab was determined. Post-dose refers to the data collected for 30 minutes post-infusion. "C" in the timeframe below refers to "Cycle" and D refers to "Day" and "h" refers to "hours".
Outcome measures
| Measure |
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
n=9 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=11 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab
Cycle 2 Day 1- Pre-dose
|
42.52 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 58
|
30.53 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 58
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab
Cycle 1 Day 1- 24 h
|
230.81 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 29
|
201.98 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 20
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab
Cycle 1 Day 1- 72 h
|
138.16 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 43
|
141.37 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab
Cycle 1 Day 1- 168 h
|
102.68 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 27
|
99.84 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 20
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab
Cycle 1 Day 1- 336 h
|
67.27 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 52
|
59.10 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab
Cycle 1 Day 1- Predose
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab
Cycle 1 Day 1- Post-dose
|
313.57 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 21
|
267.78 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab
Cycle 2 Day 1- Post-dose
|
336.36 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 24
|
316.63 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab
Cycle 5 Day 1- Pre-dose
|
105.00 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
43.02 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 20
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab
Cycle 5 Day 1- Post-dose
|
458.00 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
360.55 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab
Cycle 5 Day 1- 168 h
|
217.00 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
126.19 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab
Cycle 5 Day 1- 336 h
|
200.00 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
76.09 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab
Cycle 6 Day 1- Pre-dose
|
132.00 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
53.96 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab
Cycle 6 Day 1- Post-dose
|
552.00 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
355.69 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab
Cycle 9 Day 1- Pre-dose
|
131.00 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
66.92 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab
Cycle 13 Day 1- Pre-dose
|
96.50 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
61.30 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (pre-dose), Cycle 1 Day 1 (post-dose), Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose), Cycle 5 Day 1 (post-dose), Cycle 6 Day 1 (pre-dose), Cycle 9 Day 1 (pre-dose), Cycle 13 Day 1 (pre-dose) (each cycle = 21 days)Population: Analysis was performed on PK Analysis set. Here number analyzed = participants with available data for analysis of serum concentrations. Data was not collected and analyzed for the "Phase 1: Dose Verification: Cohort 1A arm" because tislelizumab was not administered in that arm.
Serum concentrations of tislelizumab were determined. Post-dose refers to the data collected for 30 minutes post-infusion.
Outcome measures
| Measure |
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
n=11 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab
Cycle 1 Day 1- Pre-dose
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab
Cycle 1 Day 1 Post-dose
|
62.35 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab
Cycle 2 Day 1- Pre-dose
|
14.67 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab
Cycle 5 Day 1- Pre-dose
|
33.34 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab
Cycle 5 Day 1- Post-dose
|
117.68 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab
Cycle 6 Day 1- Pre-dose
|
36.41 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab
Cycle 9 Day 1- Pre-dose
|
46.76 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab
Cycle 13 Day 1- Pre-dose
|
48.30 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 32.2 months (Dose escalation cohorts) and up to 11 months (Dose verification cohorts)Population: Analysis was performed on ADA Analysis Set that included all participants who received at least 1 dose of any component of study drugs for whom both baseline antidrug antibody result and at least 1 corresponding post-baseline antidrug antibody result are available. Here, number analyzed = participants with available data for the ADA analysis and "0" in the number analyzed signifies no participant were available for analysis at specified time-points.
Immunogenic responses to ociperlimab and tislelizumab 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: Ociperlimab 50 mg + Tislelizumab 200 mg
n=1 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=3 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=6 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=16 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=6 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
n=9 Participants
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=11 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Ociperlimab: Treatment-Emergent ADAs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Ociperlimab: Treatment-Induced ADAs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Ociperlimab: Treatment-Boosted ADAs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Ociperlimab: NAb Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Tislelizumab: Treatment-Emergent ADAs
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Tislelizumab: Treatment-Induced ADAs
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Tislelizumab: Treatment-Boosted ADAs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Tislelizumab: NAb Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: Up to 41.6 months [Cohorts 1 to 9] and up to 21.4 months [Cohort 10])Population: Analysis was performed on participants in efficacy evaluable analysis set with an objective response.
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: Ociperlimab 50 mg + Tislelizumab 200 mg
n=22 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=23 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=18 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=27 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=2 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
n=13 Participants
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=2 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
n=13 Participants
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
n=30 Participants
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
n=8 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=5 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
n=8 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b: DOR as Per RECIST v.1.1
|
16.9 months
Interval 5.6 to
Upper limit of 95% CI could not be calculated due to an insufficient number of participants with a response.
|
13.9 months
Interval 8.2 to
Upper limit of 95% CI could not be calculated due to an insufficient number of participants with a response.
|
14.0 months
Interval 2.9 to
Upper limit of 95% CI could not be calculated due to an insufficient number of participants with a response.
|
4.1 months
Interval 3.4 to 5.6
|
15.9 months
Interval 12.6 to
Upper limit of 95% CI could not be calculated due to an insufficient number of participants with a response.
|
8.0 months
Interval 5.3 to 10.9
|
3.4 months
Interval 2.1 to
Upper limit of 95% CI could not be calculated due to an insufficient number of participants with a response.
|
8.5 months
Interval 2.8 to
Upper limit of 95% CI could not be calculated due to an insufficient number of participants with a response.
|
8.4 months
Interval 5.6 to 13.4
|
16.6 months
Interval 3.9 to
Upper limit of 95% CI could not be calculated due to an insufficient number of participants with a response.
|
NA months
Interval 6.3 to
Median and upper limit of 95% CI could not be calculated due to an insufficient number of participants with a response.
|
8.3 months
Interval 5.3 to
Upper limit of 95% CI could not be calculated due to an insufficient number of participants with a response.
|
SECONDARY outcome
Timeframe: From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: Up to 41.6 months [Cohorts 1 to 9] and up to 21.4 months [Cohort 10])Population: Analysis was performed on efficacy evaluable analysis set.
DCR was defined as the percentage of participants with BOR, as per RECIST v.1.1, of a CR, PR, or SD. 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 \< 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 was defined as 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: Ociperlimab 50 mg + Tislelizumab 200 mg
n=40 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=42 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=45 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=41 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=26 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
n=19 Participants
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=6 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
n=39 Participants
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
n=59 Participants
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
n=23 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=19 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
n=23 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b: DCR as Per RECIST v.1.1
|
90.0 percentage of participants
Interval 76.3 to 97.2
|
92.9 percentage of participants
Interval 80.5 to 98.5
|
86.7 percentage of participants
Interval 73.2 to 94.9
|
90.2 percentage of participants
Interval 76.9 to 97.3
|
53.8 percentage of participants
Interval 33.4 to 73.4
|
94.7 percentage of participants
Interval 74.0 to 99.9
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
69.2 percentage of participants
Interval 52.4 to 83.0
|
86.4 percentage of participants
Interval 75.0 to 94.0
|
34.8 percentage of participants
Interval 16.4 to 57.3
|
26.3 percentage of participants
Interval 9.1 to 51.2
|
34.8 percentage of participants
Interval 16.4 to 57.3
|
SECONDARY outcome
Timeframe: From first dose of study drugs to the date of the first documentation of PD or death, whichever came first (Maximum time duration on study: up to 41.6 months [Cohorts 1 to 9] and up to 21.4 months [Cohort 10])Population: Analysis was performed on safety analysis set.
PFS was defined as the time from the date of the first dose of study drugs to the date of the first documentation of PD assessed by the investigator using RECIST v1.1 or death, whichever occurred first. PFS was estimated using the Kaplan-Meier method. 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: Ociperlimab 50 mg + Tislelizumab 200 mg
n=41 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=43 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=45 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=43 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=26 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
n=21 Participants
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=6 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
n=41 Participants
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
n=60 Participants
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
n=24 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=21 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
n=23 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b: Progression Free Survival (PFS) as Per RECIST v.1.1
|
8.2 months
Interval 6.0 to 18.1
|
11.3 months
Interval 8.0 to 20.7
|
5.5 months
Interval 4.2 to 8.2
|
4.9 months
Interval 4.2 to 5.5
|
2.9 months
Interval 1.4 to 5.3
|
7.9 months
Interval 4.1 to 10.7
|
4.9 months
Interval 2.0 to
Upper limit of 95% CI could not be calculated due to an insufficient number of participants with events.
|
5.7 months
Interval 3.0 to 8.3
|
7.3 months
Interval 5.1 to 9.5
|
2.8 months
Interval 1.4 to 6.8
|
1.9 months
Interval 1.2 to 9.0
|
8.2 months
Interval 5.5 to 11.0
|
SECONDARY outcome
Timeframe: Up to 30 days after the last dose of study interventions (Maximum time duration on study: up to 41.6 months [Cohorts 1 to 9] and up to 21.4 months [Cohort 10])Population: Analysis was performed on safety 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: Ociperlimab 50 mg + Tislelizumab 200 mg
n=41 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=43 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=45 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=43 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=26 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
n=21 Participants
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=6 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
n=41 Participants
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
n=60 Participants
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
n=24 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=21 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
n=23 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs
Participants with any TEAE
|
41 Participants
|
43 Participants
|
44 Participants
|
43 Participants
|
25 Participants
|
21 Participants
|
6 Participants
|
41 Participants
|
60 Participants
|
23 Participants
|
18 Participants
|
23 Participants
|
|
Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs
Participants with >= Grade 3 TEAE
|
30 Participants
|
33 Participants
|
17 Participants
|
31 Participants
|
12 Participants
|
16 Participants
|
6 Participants
|
27 Participants
|
49 Participants
|
9 Participants
|
10 Participants
|
15 Participants
|
|
Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs
Serious TEAE
|
21 Participants
|
28 Participants
|
15 Participants
|
23 Participants
|
9 Participants
|
11 Participants
|
4 Participants
|
22 Participants
|
32 Participants
|
10 Participants
|
8 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (pre-dose), Cycle 1 Day 1 (post-dose), Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose and post-dose), pre-dose on Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1 and Cycle 25 Day 1 (each cycle = 21 days)Population: Analysis was performed on PK analysis set. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure and 'number analyzed' = the number of participants with available data for the analysis of serum concentrations and "0" in the number analyzed signifies no participant with available data at specified time-points.
Serum concentrations of ociperlimab were determined. Post-dose refers to the data collected for 30 minutes post-infusion.
Outcome measures
| Measure |
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
n=41 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=43 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=45 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=43 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=26 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
n=21 Participants
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=6 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
n=41 Participants
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
n=59 Participants
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab
Cycle 1 Day 1-Pre-dose
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab
Cycle 1 Day 1- Post-dose
|
293.20 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 30
|
296.90 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 24
|
287.70 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 23
|
282.22 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 28
|
259.50 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 30
|
295.38 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 30
|
212.61 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 23
|
308.25 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 27
|
251.33 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab
Cycle 2 Day 1- Pre-dose
|
32.06 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 51
|
35.93 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 62
|
32.63 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 55
|
34.69 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 38
|
30.98 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 101
|
33.09 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 52
|
19.74 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 249
|
37.52 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 62
|
32.52 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 53
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab
Cycle 5 Day 1- Pre-dose
|
70.55 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 50
|
80.94 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 75
|
65.66 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 64
|
72.81 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 42
|
79.91 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 86
|
90.20 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 34
|
69.98 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 62
|
67.90 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 100
|
70.39 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 46
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab
Cycle 5 Day 1- Post-dose
|
386.03 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 25
|
382.09 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 23
|
354.15 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 21
|
344.61 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 24
|
329.26 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 20
|
338.17 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 22
|
327.12 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 29
|
391.94 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 25
|
324.40 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 31
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab
Cycle 6 Day 1- Pre-dose
|
77.56 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 51
|
88.71 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 60
|
68.12 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 59
|
77.98 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 47
|
88.08 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 85
|
74.72 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 102
|
127.53 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 25
|
77.27 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 78
|
68.02 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 73
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab
Cycle 9 Day 1- Pre-dose
|
78.12 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 68
|
103.40 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 61
|
78.16 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 44
|
85.51 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 49
|
101.98 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 87
|
85.98 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 48
|
171.57 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 38
|
94.91 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 68
|
73.16 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 88
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab
Cycle 13 Day 1- Pre-dose
|
98.90 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 35
|
112.33 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 66
|
90.14 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 48
|
92.58 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 34
|
76.79 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 65
|
85.49 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 61
|
—
|
105.69 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 74
|
94.79 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 58
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab
Cycle 17 Day 1- Pre-dose
|
89.49 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 45
|
111.36 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 43
|
91.84 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 39
|
93.32 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 68
|
14.78 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 6698
|
78.30 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 9
|
—
|
104.02 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 76
|
101.27 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 66
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab
Cycle 25 Day 1- Pre-dose
|
102.28 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 35
|
120.07 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 37
|
85.34 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 47
|
97.04 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 51
|
72.98 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 85
|
56.00 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
—
|
—
|
58.44 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 96
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (pre-dose and post-dose), Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose and post-dose), pre-dose on Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1 and Cycle 25 Day 1 (each cycle = 21 days)Population: Analysis was performed on PK analysis set. Here, number analyzed' = participants with available data for the analysis of serum concentrations and "0" in the number analyzed signifies no participant with available data at specified time-points.
Serum concentrations of tislelizumab were determined. Post-dose refers to the data collected for 30 minutes post-infusion.
Outcome measures
| Measure |
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
n=41 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=43 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=45 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=43 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=26 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
n=21 Participants
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=6 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
n=41 Participants
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
n=60 Participants
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab
Cycle 17 Day 1-Pre-dose
|
46.36 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 35
|
48.39 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 29
|
46.91 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 20
|
48.96 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 55
|
51.48 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 11
|
36.71 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 10
|
—
|
48.23 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 68
|
40.14 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 86
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab
Cycle 2 Day 1-Pre-dose
|
16.16 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 33
|
17.22 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 48
|
16.51 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 32
|
17.00 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 32
|
29.46 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 59
|
14.31 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 35
|
12.58 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 36
|
17.33 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 41
|
13.91 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 38
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab
Cycle 1 Day 1-Pre-dose
|
2.13 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
45.40 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
35.20 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
1.35 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
25.78 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
36.00 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab
Cycle 1 Day 1-Post-dose
|
68.69 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 19
|
70.24 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 21
|
70.07 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 21
|
65.59 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 27
|
86.72 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 28
|
65.15 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 22
|
52.88 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 11
|
69.50 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 19
|
59.14 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 23
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab
Cycle 5 Day 1-Pre-dose
|
36.32 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 43
|
35.45 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 98
|
31.50 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 65
|
38.54 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 35
|
36.32 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 46
|
39.78 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 22
|
28.96 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 50
|
37.33 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 67
|
29.46 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 48
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab
Cycle 5 Day 1-Post-dose
|
105.78 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 28
|
107.03 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 29
|
105.03 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 24
|
104.12 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 23
|
100.39 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 20
|
97.03 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 24
|
72.73 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 26
|
109.71 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 28
|
86.46 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab
Cycle 6 Day 1-Pre-dose
|
38.56 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 40
|
37.47 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 95
|
34.48 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 47
|
39.78 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 36
|
39.30 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 47
|
36.91 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 93
|
44.63 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 47
|
43.60 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 48
|
29.37 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 64
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab
Cycle 9 Day 1-Pre-dose
|
40.32 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 54
|
37.29 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 128
|
40.98 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 45
|
47.24 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 29
|
42.50 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 53
|
40.62 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 48
|
63.54 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 77
|
48.29 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 51
|
27.03 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 138
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab
Cycle 13 Day 1-Pre-dose
|
48.48 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 35
|
47.22 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 42
|
43.46 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 28
|
51.62 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 16
|
45.87 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 59
|
38.19 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 30
|
—
|
47.08 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 70
|
36.61 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 75
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab
Cycle 25 Day 1-Pre-dose
|
48.48 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 25
|
52.34 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 26
|
44.47 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 30
|
49.65 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 40
|
42.97 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 35
|
21.40 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
—
|
—
|
16.83 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 117
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, post-dose, 168 h, 336 h post-dose Cycle1 Day 1, Pre-dose on Cycle 2 Day 1, Pre-dose, post-dose (30 min) on Cycle 5 Day 1, Pre-dose on Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, and Cycle 25 Day 1 (each cycle = 21 days)Population: Analysis was performed on PK analysis set. Here, 'number analyzed' = participants with available data for the analysis of serum concentrations and "0" in the number analyzed signifies that no participant with available data at the specified time-point.
Serum concentrations of ociperlimab were determined. Post-dose refers to the data collected for 30 minutes post-infusion and 'h' in the time-frame section refers to hours.
Outcome measures
| Measure |
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
n=24 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=21 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=23 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab
Cycle 1 Day 1- Pre-dose
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
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—
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—
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—
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—
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—
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—
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Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab
Cycle 1 Day 1- Post-dose
|
147.73 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 21
|
309.74 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 15
|
580.37 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 15
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—
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—
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—
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—
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—
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—
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—
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Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab
Cycle 1 Day 1- 168 h
|
44.61 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 32
|
99.03 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 25
|
178.34 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 26
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab
Cycle 1 Day 1- 336 h
|
25.65 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 41
|
56.73 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 49
|
103.48 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 31
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab
Cycle 2 Day 1- Pre-dose
|
13.02 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 66
|
31.60 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 49
|
64.10 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 33
|
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—
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—
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—
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Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab
Cycle 5 Day 1- Pre-dose
|
40.02 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 54
|
67.49 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 49
|
95.90 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 82
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—
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—
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—
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Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab
Cycle 5 Day 1- Post-dose
|
217.47 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 16
|
404.63 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 20
|
664.37 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 13
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab
Cycle 6 Day 1- Pre-dose
|
27.74 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 331
|
68.08 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 54
|
110.97 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 45
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab
Cycle 9 Day 1- Pre-dose
|
55.13 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 31
|
86.59 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 95
|
89.60 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 166
|
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—
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—
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—
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Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab
Cycle 13 Day 1- Pre-dose
|
61.11 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 41
|
86.89 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 32
|
142.18 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 36
|
—
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—
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—
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—
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—
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—
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—
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Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab
Cycle 17 Day 1- Pre-dose
|
52.56 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 22
|
105.58 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 23
|
119.15 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 21
|
—
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—
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—
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Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab
Cycle 25 Day 1- Pre-dose
|
108.00 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
—
|
125.00 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
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SECONDARY outcome
Timeframe: Cycle 1 Day 1 (pre-dose and post-dose, Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose and post-dose), pre-dose of Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1 and Cycle 25 Day 1 (each cycle = 21 days)Population: Analysis was performed on PK analysis set. Here, 'number analyzed' = participants with available data for the analysis of serum concentrations and "0" in the number analyzed signifies that no participant with available data at the specified time-point.
Serum concentrations of tislelizumab were determined. Post-dose refers to the data collected for 30 minutes post-infusion.
Outcome measures
| Measure |
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
n=24 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=21 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=23 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab
Cycle 13 Day 1-Pre-dose
|
73.38 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 19
|
42.67 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 36
|
37.52 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 20
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab
Cycle 1 Day 1-Pre-dose
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
|
2.94 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 317
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
Geometric mean and GCV could not be calculated due to an insufficient number of participants with LLOQ for analysis.
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—
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—
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Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab
Cycle 1 Day 1-Post-dose
|
68.42 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 24
|
67.97 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 12
|
63.62 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 17
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—
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Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab
Cycle 2 Day 1-Pre-dose
|
13.81 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 45
|
14.87 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 31
|
14.70 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 32
|
—
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—
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—
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—
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Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab
Cycle 5 Day 1-Pre-dose
|
36.10 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 43
|
35.56 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 34
|
25.24 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 52
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—
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—
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Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab
Cycle 5 Day 1-Post-dose
|
117.14 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 27
|
103.69 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 16
|
90.46 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 17
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—
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—
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—
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Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab
Cycle 6 Day 1-Pre-dose
|
34.73 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 80
|
35.17 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 34
|
28.70 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 39
|
—
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—
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—
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Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab
Cycle 9 Day 1-Pre-dose
|
53.01 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 29
|
48.07 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 64
|
25.96 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 110
|
—
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—
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—
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—
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—
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Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab
Cycle 17 Day 1-Pre-dose
|
59.21 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 13
|
55.86 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 18
|
29.99 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 40
|
—
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Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab
Cycle 25 Day 1-Pre-dose
|
82.30 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
—
|
32.80 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
GCV could not be calculated due to an insufficient number of participants available for analysis.
|
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SECONDARY outcome
Timeframe: Up to 34.4 months (Cohorts 1 to 9) and up to 20.8 months (Cohort 10)Population: Analysis was performed on ADA Analysis set. Here, number analyzed = participants with available data for ADA analysis.
Immunogenic responses to ociperlimab and 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: Ociperlimab 50 mg + Tislelizumab 200 mg
n=41 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=43 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=45 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=43 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=26 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
n=21 Participants
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=6 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
n=41 Participants
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
n=60 Participants
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
n=24 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=21 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
n=23 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Ociperlimab: Treatment-Emergent ADAs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Ociperlimab: Treatment-Boosted ADAs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Ociperlimab: Treatment-Induced ADAs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Ociperlimab NAb positive
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Tislelizumab: Treatment-Emergent ADAs
|
24 Participants
|
17 Participants
|
17 Participants
|
12 Participants
|
3 Participants
|
11 Participants
|
2 Participants
|
10 Participants
|
17 Participants
|
11 Participants
|
6 Participants
|
9 Participants
|
|
Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Tislelizumab: Treatment-Boosted ADAs
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Tislelizumab: Treatment-Induced ADAs
|
22 Participants
|
16 Participants
|
16 Participants
|
11 Participants
|
3 Participants
|
11 Participants
|
2 Participants
|
9 Participants
|
17 Participants
|
9 Participants
|
5 Participants
|
9 Participants
|
|
Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Tislelizumab NAb positive
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)Population: Analysis was performed on efficacy evaluable analysis set for participants with available TIGIT or PD-L1 expression levels. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure and "number analyzed" signifies participants with available data for each specified category at respective visit and "0" in the number analyzed defines no participant were available for analysis at specified time-points.
Archival or fresh tumor samples were collected for analysis of biomarkers for T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) and PD-L1 expression. The TIGIT expression on immune cells (IC) and the classification thresholds were different for various cohorts. For Cohort 4, TIGIT IC was categorized as \<1% or \>=1%; for Cohorts 1, 2, 3, 5, 6, 8, 9 and 10, TIGIT IC was categorized as \<5% or \>=5%. ORR is reported for each TIGIT subgroup as relevant in each cohort. Biomarker data were not analyzed and reported for participants in Cohort 7.
Outcome measures
| Measure |
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
n=24 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=28 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=44 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=26 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=17 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
n=18 Participants
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
n=39 Participants
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
n=54 Participants
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
n=22 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=19 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
n=22 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression
ORR: TIGIT IC < 1%
|
—
|
—
|
—
|
58.3 percentage of participants
Interval 27.7 to 84.8
|
—
|
—
|
—
|
—
|
—
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
16.7 percentage of participants
Interval 2.1 to 48.4
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
|
Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression
ORR: TIGIT IC >= 1%
|
—
|
—
|
—
|
57.1 percentage of participants
Interval 28.9 to 82.3
|
—
|
—
|
—
|
—
|
—
|
38.5 percentage of participants
Interval 13.9 to 68.4
|
42.9 percentage of participants
Interval 9.9 to 81.6
|
38.5 percentage of participants
Interval 13.9 to 68.4
|
|
Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression
ORR: TIGIT IC < 5%
|
54.5 percentage of participants
Interval 23.4 to 83.3
|
66.7 percentage of participants
Interval 38.4 to 88.2
|
17.6 percentage of participants
Interval 3.8 to 43.4
|
—
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
—
|
36.4 percentage of participants
Interval 10.9 to 69.2
|
56.0 percentage of participants
Interval 34.9 to 75.6
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression
ORR: TIGIT IC >= 5%
|
61.5 percentage of participants
Interval 31.6 to 86.1
|
38.5 percentage of participants
Interval 13.9 to 68.4
|
55.6 percentage of participants
Interval 35.3 to 74.5
|
—
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
70.0 percentage of participants
Interval 34.8 to 93.3
|
—
|
32.1 percentage of participants
Interval 15.9 to 52.4
|
44.8 percentage of participants
Interval 26.4 to 64.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)Population: Analysis was performed on efficacy evaluable analysis set for participants with available PD-L1 expression levels. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure and "number analyzed" signifies participants with available data for each specified category at respective visit and "0" in the number analyzed defines no participant were available for analysis at specified time-points.
Archival or fresh tumor samples were collected for analysis of biomarkers for T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) and PD-L1 expression. The PD-L1 expression scoring algorithm and the classification thresholds were also different for various cohorts as follows: For Cohort 1 and Cohort 2, PD-L1 TC \<1% or \>= 1%; for Cohorts 3, 5, and 10, PD-L1 TC \< 50% or \>=50%; for Cohort 4, PD-L1 tumor area positivity (TAP) \<1% or \>=1%; for Cohort 9, PD-L1 TAP \< 5% or \>= 5%; for Cohort 6 and 8, PD-L1 TAP \<10% or \>=10%. ORR is reported for each PD-L1 subgroup as relevant in each cohort. Biomarker data were not analyzed and reported for participants in Cohort 7.
Outcome measures
| Measure |
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
n=25 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=29 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=45 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=24 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=17 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
n=17 Participants
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
n=37 Participants
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
n=55 Participants
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
n=23 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=19 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
n=23 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression
ORR: PD-L1 TC < 1%
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
60.0 percentage of participants
Interval 32.3 to 83.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression
ORR: PD-L1 TC >= 1%
|
56.3 percentage of participants
Interval 29.9 to 80.2
|
42.9 percentage of participants
Interval 17.7 to 71.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression
ORR: PD-L1 TC < 50%
|
—
|
—
|
30.8 percentage of participants
Interval 14.3 to 51.8
|
—
|
0.0 percentage of participants
Interval 0.0 to 26.5
|
—
|
—
|
—
|
—
|
46.7 percentage of participants
Interval 21.3 to 73.4
|
18.2 percentage of participants
Interval 2.3 to 51.87
|
26.7 percentage of participants
Interval 7.8 to 55.1
|
|
Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression
ORR: PD-L1 TC >= 50%
|
—
|
—
|
52.6 percentage of participants
Interval 28.9 to 75.6
|
—
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
—
|
—
|
—
|
—
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
37.5 percentage of participants
Interval 8.5 to 75.5
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
|
Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression
ORR: PD-L1 TAP < 1%
|
—
|
—
|
—
|
56.3 percentage of participants
Interval 29.9 to 80.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression
ORR: PD-L1 TAP >= 1%
|
—
|
—
|
—
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression
ORR: PD-L1 TAP < 5%
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
50.0 percentage of participants
Interval 30.6 to 69.4
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression
ORR: PD-L1 TAP >= 5%
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
55.6 percentage of participants
Interval 35.3 to 74.5
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression
ORR: PD-L1 TAP < 10%
|
—
|
—
|
—
|
—
|
—
|
61.5 percentage of participants
Interval 31.6 to 86.1
|
—
|
31.3 percentage of participants
Interval 11.0 to 58.7
|
—
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression
ORR: PD-L1 TAP >= 10%
|
—
|
—
|
—
|
—
|
—
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
—
|
38.1 percentage of participants
Interval 18.1 to 61.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)Population: Analysis was performed on efficacy evaluable analysis set. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure and "number analyzed" signifies participants with available data for each specified category at respective visit and "0" in the number analyzed defines no participant were available for analysis at specified time-points.
Archival or fresh tumor samples were collected for analysis of biomarkers for T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) and PD-L1 expression. The TIGIT expression on immune cells and the classification thresholds were different for various cohorts. For Cohort 4, TIGIT IC was categorized as \<1% or \>=1%; for Cohorts 1, 2, 3, 5, 6, 8, 9 and 10, TIGIT IC was categorized as \<5% or \>=5%. Median PFS (mPFS) is reported for each TIGIT subgroup as relevant in each cohort. Biomarker data were not analyzed and reported for participants in Cohort 7.
Outcome measures
| Measure |
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
n=25 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=29 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=44 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=27 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=17 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
n=19 Participants
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
n=41 Participants
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
n=55 Participants
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
n=23 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=21 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
n=22 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression
mPFS: TIGIT IC < 5%
|
7.0 months
Interval 3.4 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
10.9 months
Interval 5.3 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
5.4 months
Interval 2.6 to 15.0
|
—
|
3.8 months
Interval 1.2 to 5.3
|
8.1 months
Interval 0.4 to 12.3
|
—
|
6.1 months
Interval 4.0 to 12.5
|
6.9 months
Interval 4.1 to 11.1
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression
mPFS: TIGIT IC >= 5%
|
6.9 months
Interval 3.9 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
12.6 months
Interval 5.4 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
5.5 months
Interval 4.2 to 11.0
|
—
|
5.2 months
Interval 1.0 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
7.9 months
Interval 3.0 to 12.2
|
—
|
4.1 months
Interval 1.4 to 8.3
|
8.2 months
Interval 2.8 to 11.2
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression
mPFS: TIGIT IC < 1%
|
—
|
—
|
—
|
5.1 months
Interval 1.2 to 5.6
|
—
|
—
|
—
|
—
|
—
|
2.7 months
Interval 1.2 to 6.9
|
1.6 months
Interval 1.2 to 6.9
|
5.5 months
Interval 1.4 to 9.5
|
|
Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression
mPFS: TIGIT IC >= 1%
|
—
|
—
|
—
|
4.9 months
Interval 4.1 to 7.4
|
—
|
—
|
—
|
—
|
—
|
2.8 months
Interval 1.3 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
9.0 months
Interval 0.6 to 12.3
|
8.5 months
Interval 5.7 to 11.6
|
SECONDARY outcome
Timeframe: Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)Population: Analysis was performed on efficacy evaluable analysis set. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure and "number analyzed" signifies participants with available data for each specified category at respective visit and "0" in the number analyzed defines no participant were available for analysis at specified time-points.
Archival or fresh tumor samples were collected for analysis of biomarkers for T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) and PD-L1 expression. The PD-L1 expression scoring algorithm and the classification thresholds were also different for various cohorts as follows: For Cohort 1 and Cohort 2, PD-L1 TC \<1% or \>= 1%; for Cohorts 3, 5, and 10, PD-L1 TC \< 50% or \>=50%; for Cohort 4, PD-L1 tumor area positivity (TAP) \<1% or \>=1%; for Cohort 9, PD-L1 TAP \< 5% or \>= 5%; for Cohort 6 and 8, PD-L1 TAP \<10% or \>=10%. mPFS is reported for each PD-L1 subgroup as relevant in each cohort. Biomarker data were not analyzed and reported for participants in Cohort 7.
Outcome measures
| Measure |
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
n=26 Participants
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=30 Participants
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=45 Participants
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=25 Participants
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=17 Participants
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
n=18 Participants
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 8
n=39 Participants
Participants with recurrent or metastatic HNSCC (PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Expansion: Cohort 9
n=56 Participants
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
n=24 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=21 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
n=23 Participants
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression
mPFS: PD-L1 TC < 50%
|
—
|
—
|
5.2 months
Interval 3.0 to 5.5
|
—
|
1.6 months
Interval 1.2 to 5.0
|
—
|
—
|
—
|
—
|
6.4 months
Interval 1.2 to
Upper limit of 95% CI could not be calculated due to an insufficient number of participants with events.
|
1.4 months
Interval 1.1 to 6.9
|
8.5 months
Interval 4.2 to 11.6
|
|
Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression
mPFS: PD-L1 TC < 1%
|
7.0 months
Interval 0.3 to
Upper limit of 95% CI could not be calculated due to an insufficient number of participants with events.
|
23.6 months
Interval 5.4 to
Upper limit of 95% CI could not be calculated due to an insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression
mPFS: PD-L1 TC >= 1%
|
6.9 months
Interval 5.4 to
Upper limit of 95% CI could not be calculated due to an insufficient number of participants with events.
|
8.0 months
Interval 6.3 to 16.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression
mPFS: PD-L1 TC >= 50%
|
—
|
—
|
8.2 months
Interval 4.2 to 23.9
|
—
|
20.6 months
Interval 1.4 to
Upper limit of 95% CI could not be calculated due to an insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
2.6 months
Interval 1.3 to 5.5
|
9.0 months
Interval 0.6 to 12.3
|
6.8 months
Interval 1.4 to
Upper limit of 95% CI could not be calculated due to an insufficient number of participants with events.
|
|
Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression
mPFS: PD-L1 TAP < 1%
|
—
|
—
|
—
|
5.1 months
Interval 4.1 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression
mPFS: PD-L1 TAP >= 1%
|
—
|
—
|
—
|
5.4 months
Interval 0.7 to 7.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression
mPFS: PD-L1 TAP < 5%
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.7 months
Interval 2.8 to 9.1
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression
mPFS: PD-L1 TAP >= 5%
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8.2 months
Interval 3.9 to 11.1
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression
mPFS: PD-L1 TAP < 10%
|
—
|
—
|
—
|
—
|
—
|
7.6 months
Interval 3.7 to 10.7
|
—
|
4.0 months
Interval 1.2 to 12.4
|
—
|
—
|
—
|
—
|
|
Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression
mPFS: PD-L1 TAP >= 10%
|
—
|
—
|
—
|
—
|
—
|
10.3 months
Interval 2.7 to
Upper limit of 95% CI could not be calculated due to an insufficient number of participants with events.
|
—
|
7.1 months
Interval 3.0 to 9.7
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 4 deaths
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
Serious events: 9 serious events
Other events: 13 other events
Deaths: 7 deaths
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
Serious events: 3 serious events
Other events: 8 other events
Deaths: 4 deaths
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
Serious events: 5 serious events
Other events: 11 other events
Deaths: 3 deaths
Phase 1b: Dose Expansion: Cohort 1
Serious events: 21 serious events
Other events: 40 other events
Deaths: 24 deaths
Phase 1b: Dose Expansion: Cohort 2
Serious events: 28 serious events
Other events: 42 other events
Deaths: 24 deaths
Phase 1b: Dose Expansion: Cohort 3
Serious events: 15 serious events
Other events: 44 other events
Deaths: 22 deaths
Phase 1b: Dose Expansion: Cohort 4
Serious events: 23 serious events
Other events: 41 other events
Deaths: 35 deaths
Phase 1b: Dose Expansion: Cohort 5
Serious events: 9 serious events
Other events: 24 other events
Deaths: 18 deaths
Phase 1b: Dose Expansion: Cohort 6
Serious events: 11 serious events
Other events: 21 other events
Deaths: 14 deaths
Phase 1b: Dose Expansion: Cohort 7
Serious events: 4 serious events
Other events: 6 other events
Deaths: 6 deaths
Phase 1b: Dose Expansion: Cohort 8
Serious events: 22 serious events
Other events: 39 other events
Deaths: 19 deaths
Phase 1b: Dose Expansion: Cohort 9
Serious events: 32 serious events
Other events: 59 other events
Deaths: 42 deaths
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
Serious events: 8 serious events
Other events: 17 other events
Deaths: 8 deaths
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
Serious events: 10 serious events
Other events: 22 other events
Deaths: 9 deaths
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
Serious events: 13 serious events
Other events: 23 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
n=1 participants at risk
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=3 participants at risk
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=6 participants at risk
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=16 participants at risk
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=6 participants at risk
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
n=9 participants at risk
Participants received ociperlimab 900 mg as monotherapy as IV infusion on Day 1 of each 21-day treatment cycle and will be followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=11 participants at risk
Participants received ociperlimab 900 mg as IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Expansion: Cohort 1
n=41 participants at risk
Participants with metastatic squamous NSCLC received treatment with ociperlimab 900 mg IV infusion along with tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle. Participants also received 4 to 6 cycles of chemo with carboplatin AUC 5 or 6 (Day 1) + paclitaxel 200 or 175 mg/m\^2 (Day 1) or nab paclitaxel 100 mg/m\^2 (Days 1, 8 and 15) Q3W and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Expansion: Cohort 2
n=43 participants at risk
Participants with metastatic NSCLC (PD-L1 positive, TC\>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle. Participants also received cisplatin 75 mg/m\^2 or carboplatin (AUC 5) and pemetrexed 500 mg/m\^2 (on Day 1) Q3W for 4-6 cycles followed by ociperlimab 900 mg + tislelizumab 200 mg + pemetrexed 500 mg/m\^2 on Day 1 Q3W and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Expansion: Cohort 3
n=45 participants at risk
Participants with metastatic NSCLC (PD-L1 positive, TC \>=1%) were treated with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Expansion: Cohort 4
n=43 participants at risk
Participants with extensive-stage SCLC received treatment with ociperlimab 900 mg IV infusion, tislelizumab 200 mg IV infusion. Participants also received 4 cycles of etoposide 100 mg/m\^2 (on Days 1, 2, 3), and cisplatin 75 mg/m\^2 /carboplatin AUC 5 (Day 1) Q3W, followed by ociperlimab 900 mg (Day 1) + tislelizumab 200 mg (Day 1) Q3W and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Expansion: Cohort 5
n=26 participants at risk
Checkpoint inhibitor (CPI)-experienced NSCLC participants received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of each 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Expansion: Cohort 6
n=21 participants at risk
Participants with metastatic ESCC received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, cisplatin 75 mg/m\^2 (Day 1), and Fluorouracil 750-800 mg/m\^2 (5-FU; Day 1 to Day 5) or paclitaxel 200 or 175 mg/m\^2 (Day 1) Q3W followed by ociperlimab 900 mg and tislelizumab 200 mg on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Expansion: Cohort 7
n=6 participants at risk
Participants with metastatic EAC received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, cisplatin 75 mg/m\^2 (Day 1), and Fluorouracil 750-800 mg/m\^2 (5-FU; Day 1 to Day 5) or paclitaxel 200 or 175 mg/m\^2 (Day 1) Q3W followed by ociperlimab 900 mg and tislelizumab 200 mg on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Expansion: Cohort 8
n=41 participants at risk
Participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC; PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Expansion: Cohort 9
n=60 participants at risk
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=21 participants at risk
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
n=24 participants at risk
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
n=23 participants at risk
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
5.0%
3/60 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Generalised oedema
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Malaise
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Human rhinovirus test positive
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Medical device pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Influenza
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.7%
2/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Atrial flutter
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Endocrine disorders
Primary adrenal insufficiency
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
12.5%
2/16 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
5.0%
3/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Gastrointestinal vascular malformation haemorrhagic
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Asthenia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
5.0%
3/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Chills
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Death
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.3%
2/24 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Disease progression
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
General physical health deterioration
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Hepatobiliary disorders
Immune-mediated cholestasis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.0%
6/43 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.7%
2/26 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
19.5%
8/41 • Number of events 10 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
13.0%
3/23 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Subdural abscess
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Injury, poisoning and procedural complications
Peripheral nerve injury
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Injury, poisoning and procedural complications
Shoulder fracture
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Troponin I increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Troponin increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Somatic dysfunction
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial effusion malignant
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.7%
2/23 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Immune-mediated dermatitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Vascular disorders
Flushing
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
Other adverse events
| Measure |
Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
n=1 participants at risk
Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
n=3 participants at risk
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
n=6 participants at risk
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
n=16 participants at risk
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
n=6 participants at risk
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
n=9 participants at risk
Participants received ociperlimab 900 mg as monotherapy as IV infusion on Day 1 of each 21-day treatment cycle and will be followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=11 participants at risk
Participants received ociperlimab 900 mg as IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Expansion: Cohort 1
n=41 participants at risk
Participants with metastatic squamous NSCLC received treatment with ociperlimab 900 mg IV infusion along with tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle. Participants also received 4 to 6 cycles of chemo with carboplatin AUC 5 or 6 (Day 1) + paclitaxel 200 or 175 mg/m\^2 (Day 1) or nab paclitaxel 100 mg/m\^2 (Days 1, 8 and 15) Q3W and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Expansion: Cohort 2
n=43 participants at risk
Participants with metastatic NSCLC (PD-L1 positive, TC\>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle. Participants also received cisplatin 75 mg/m\^2 or carboplatin (AUC 5) and pemetrexed 500 mg/m\^2 (on Day 1) Q3W for 4-6 cycles followed by ociperlimab 900 mg + tislelizumab 200 mg + pemetrexed 500 mg/m\^2 on Day 1 Q3W and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Expansion: Cohort 3
n=45 participants at risk
Participants with metastatic NSCLC (PD-L1 positive, TC \>=1%) were treated with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Expansion: Cohort 4
n=43 participants at risk
Participants with extensive-stage SCLC received treatment with ociperlimab 900 mg IV infusion, tislelizumab 200 mg IV infusion. Participants also received 4 cycles of etoposide 100 mg/m\^2 (on Days 1, 2, 3), and cisplatin 75 mg/m\^2 /carboplatin AUC 5 (Day 1) Q3W, followed by ociperlimab 900 mg (Day 1) + tislelizumab 200 mg (Day 1) Q3W and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Expansion: Cohort 5
n=26 participants at risk
Checkpoint inhibitor (CPI)-experienced NSCLC participants received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of each 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Expansion: Cohort 6
n=21 participants at risk
Participants with metastatic ESCC received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, cisplatin 75 mg/m\^2 (Day 1), and Fluorouracil 750-800 mg/m\^2 (5-FU; Day 1 to Day 5) or paclitaxel 200 or 175 mg/m\^2 (Day 1) Q3W followed by ociperlimab 900 mg and tislelizumab 200 mg on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Expansion: Cohort 7
n=6 participants at risk
Participants with metastatic EAC received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, cisplatin 75 mg/m\^2 (Day 1), and Fluorouracil 750-800 mg/m\^2 (5-FU; Day 1 to Day 5) or paclitaxel 200 or 175 mg/m\^2 (Day 1) Q3W followed by ociperlimab 900 mg and tislelizumab 200 mg on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Expansion: Cohort 8
n=41 participants at risk
Participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC; PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Expansion: Cohort 9
n=60 participants at risk
Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
n=21 participants at risk
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
n=24 participants at risk
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
n=23 participants at risk
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
5.0%
3/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.8%
4/41 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
20.9%
9/43 • Number of events 14 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.7%
3/45 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.7%
2/26 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
10.0%
6/60 • Number of events 8 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
19.0%
4/21 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.7%
2/26 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.2%
2/11 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
26.8%
11/41 • Number of events 12 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
23.3%
10/43 • Number of events 16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.7%
3/45 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
27.9%
12/43 • Number of events 17 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.7%
2/26 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
7/21 • Number of events 9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
50.0%
3/6 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
22.0%
9/41 • Number of events 9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
15.0%
9/60 • Number of events 16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.7%
2/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.3%
7/43 • Number of events 10 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
5/45 • Number of events 12 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.3%
7/43 • Number of events 10 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.5%
3/26 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
23.8%
5/21 • Number of events 8 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.8%
4/41 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
21.7%
13/60 • Number of events 18 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.7%
2/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Dry mouth
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.3%
5/60 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.3%
2/24 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
2/6 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Eosinophilic oesophagitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Gastrointestinal mucosal disorder
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.3%
4/43 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.7%
2/26 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
12.5%
2/16 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
22.0%
9/41 • Number of events 12 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
27.9%
12/43 • Number of events 40 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
24.4%
11/45 • Number of events 14 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.6%
8/43 • Number of events 13 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.7%
2/26 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
38.1%
8/21 • Number of events 13 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
40.0%
24/60 • Number of events 47 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.3%
3/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
13.0%
3/23 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Poor dental condition
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Salivary gland pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.3%
3/21 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
10/60 • Number of events 17 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.0%
6/43 • Number of events 8 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.9%
4/45 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.0%
6/43 • Number of events 8 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.7%
2/26 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.3%
3/21 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
2/6 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
25.0%
15/60 • Number of events 28 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Asthenia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
17.1%
7/41 • Number of events 17 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.0%
6/43 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.0%
6/43 • Number of events 9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
5.0%
3/60 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Catheter site pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Chest discomfort
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.3%
2/24 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Chest pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.7%
3/45 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Chills
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
27.3%
3/11 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
15.6%
7/45 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.7%
2/26 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
13.3%
8/60 • Number of events 11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
12.5%
3/24 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
66.7%
4/6 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.8%
3/16 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.2%
2/11 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.8%
4/41 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.6%
8/43 • Number of events 9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
13.3%
6/45 • Number of events 10 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.3%
4/43 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
30.8%
8/26 • Number of events 9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.3%
3/21 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
66.7%
4/6 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
12.2%
5/41 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
28.3%
17/60 • Number of events 26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
13.0%
3/23 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Gait disturbance
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Influenza like illness
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.7%
3/45 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Malaise
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.6%
6/41 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.7%
7/60 • Number of events 9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
19.0%
4/21 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Peripheral swelling
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
27.3%
3/11 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
22.0%
9/41 • Number of events 13 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.3%
4/43 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
28.9%
13/45 • Number of events 14 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.3%
4/43 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
19.0%
4/21 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
20.0%
12/60 • Number of events 17 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.3%
3/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
20.8%
5/24 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
13.0%
3/23 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
General disorders
Temperature intolerance
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
5.0%
3/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
28.6%
6/21 • Number of events 9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
13.3%
8/60 • Number of events 9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.7%
2/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
13.0%
3/23 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
3/9 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.2%
2/11 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
36.6%
15/41 • Number of events 38 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
69.8%
30/43 • Number of events 95 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
17.8%
8/45 • Number of events 9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
55.8%
24/43 • Number of events 42 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.5%
3/26 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
66.7%
14/21 • Number of events 27 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
12.2%
5/41 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
50.0%
30/60 • Number of events 45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
23.8%
5/21 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
4/24 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
30.4%
7/23 • Number of events 12 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 8 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
5.0%
3/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
10.0%
6/60 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Atrial escape rhythm
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
22.2%
2/9 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.3%
3/21 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
10.0%
6/60 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.6%
5/43 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.9%
4/45 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.3%
7/43 • Number of events 8 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
19.0%
4/21 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
22.0%
9/41 • Number of events 10 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
21.7%
13/60 • Number of events 18 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
13.0%
3/23 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.3%
2/24 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Eye disorders
Diplopia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Eye disorders
Dry eye
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Eye disorders
Eye pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Eye disorders
Glaucoma
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Eye disorders
Keratitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Eye disorders
Night blindness
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Eye disorders
Papilloedema
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.7%
2/26 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Eye disorders
Retinal drusen
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Eye disorders
Uveitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
5.0%
3/60 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.7%
3/45 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.7%
4/60 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.3%
2/24 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
5.0%
3/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
22.2%
2/9 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.2%
2/11 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
12.2%
5/41 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.3%
4/43 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
19.2%
5/26 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.3%
3/21 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.8%
4/41 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
21.7%
13/60 • Number of events 13 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
21.7%
5/23 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Weight increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.6%
6/41 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.3%
3/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.7%
4/60 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Dermatophytosis of nail
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Influenza
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Oral bacterial infection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.6%
5/43 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.9%
4/45 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.3%
3/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.8%
4/41 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
5.0%
3/60 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Septic shock
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
15.6%
7/45 • Number of events 8 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Injury, poisoning and procedural complications
Stoma site discharge
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.2%
2/11 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
24.4%
10/41 • Number of events 14 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
34.9%
15/43 • Number of events 37 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
17.8%
8/45 • Number of events 10 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.6%
5/43 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
28.6%
6/21 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.8%
4/41 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
13.3%
8/60 • Number of events 16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
4/24 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
13.0%
3/23 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Alpha hydroxybutyrate dehydrogenase increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Amylase increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.2%
2/11 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
5/45 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.3%
5/60 • Number of events 9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
13.0%
3/23 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.2%
2/11 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
24.4%
10/41 • Number of events 13 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
34.9%
15/43 • Number of events 35 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
17.8%
8/45 • Number of events 11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.0%
6/43 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
23.8%
5/21 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.8%
4/41 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
20.0%
12/60 • Number of events 21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.3%
2/24 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
17.4%
4/23 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Beta 2 microglobulin increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Bile acids increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.6%
5/43 • Number of events 10 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Bilirubin urine present
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.2%
2/11 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
12.5%
3/24 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
36.4%
4/11 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.3%
5/60 • Number of events 9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Blood bilirubin unconjugated increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Blood chloride decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.3%
3/21 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Blood cholinesterase decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.8%
4/41 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.2%
2/11 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.7%
3/45 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.7%
2/26 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
7/21 • Number of events 16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
2/6 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Blood glucose increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
22.2%
2/9 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
27.3%
3/11 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.3%
7/43 • Number of events 19 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
10.0%
6/60 • Number of events 13 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.7%
2/23 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Blood pressure increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Blood testosterone decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Blood urea increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 8 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.2%
2/11 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.6%
5/43 • Number of events 14 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Fibrinogen degradation products increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
22.2%
2/9 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.6%
5/43 • Number of events 10 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.6%
5/43 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Glucose urine present
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Glutathione reductase activity increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Glycocholic acid increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Heart rate increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Lipase increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.9%
4/45 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.6%
5/43 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.5%
3/26 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
10.0%
6/60 • Number of events 8 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
26.1%
6/23 • Number of events 9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.8%
4/41 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 14 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.3%
4/43 • Number of events 12 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.3%
5/60 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Myoglobin blood increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
43.9%
18/41 • Number of events 59 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
44.2%
19/43 • Number of events 89 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
53.5%
23/43 • Number of events 51 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
52.4%
11/21 • Number of events 28 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
20/60 • Number of events 94 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.2%
2/11 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Occult blood positive
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
3/9 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
29.3%
12/41 • Number of events 33 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
32.6%
14/43 • Number of events 26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
27.9%
12/43 • Number of events 21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
7/21 • Number of events 11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
40.0%
24/60 • Number of events 68 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Platelet count increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Protein total decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 10 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Protein urine present
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.7%
2/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Red blood cell count increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.7%
4/60 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Thyroxine decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Thyroxine free decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Thyroxine free increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Tri-iodothyronine decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.2%
2/11 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Tri-iodothyronine free increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Troponin increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Urobilinogen urine increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
Vitamin D decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
36.6%
15/41 • Number of events 66 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
41.9%
18/43 • Number of events 98 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
37.2%
16/43 • Number of events 36 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
66.7%
14/21 • Number of events 41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
31.7%
19/60 • Number of events 101 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.8%
3/16 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
27.3%
3/11 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
36.6%
15/41 • Number of events 35 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
32.6%
14/43 • Number of events 19 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
20.0%
9/45 • Number of events 10 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
19.2%
5/26 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
23.8%
5/21 • Number of events 8 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
28.3%
17/60 • Number of events 33 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
19.0%
4/21 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.3%
2/24 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.7%
2/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
5.0%
3/60 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.7%
2/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.3%
5/60 • Number of events 9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
3/9 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
36.4%
4/11 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
12.2%
5/41 • Number of events 16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.6%
5/43 • Number of events 18 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.7%
3/45 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.3%
3/21 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
5.0%
3/60 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.3%
2/24 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.7%
2/23 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.3%
5/60 • Number of events 8 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.3%
3/21 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
5.0%
3/60 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
22.2%
2/9 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.2%
2/11 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.6%
5/43 • Number of events 19 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
19.0%
4/21 • Number of events 10 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
36.4%
4/11 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
17.1%
7/41 • Number of events 13 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.0%
6/43 • Number of events 18 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.9%
4/45 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.3%
4/43 • Number of events 10 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
28.6%
6/21 • Number of events 15 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
24.4%
10/41 • Number of events 11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
23.3%
14/60 • Number of events 32 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
20.8%
5/24 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
39.1%
9/23 • Number of events 12 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
10/60 • Number of events 18 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
13.0%
3/23 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.3%
4/43 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.7%
3/45 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.0%
6/43 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
23.8%
5/21 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
13.3%
8/60 • Number of events 16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
12.5%
3/24 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.3%
4/43 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
7/21 • Number of events 10 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.7%
4/60 • Number of events 8 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.7%
2/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
44.4%
4/9 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.2%
2/11 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
12.2%
5/41 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.6%
8/43 • Number of events 20 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.0%
6/43 • Number of events 10 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
28.6%
6/21 • Number of events 10 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
19.5%
8/41 • Number of events 11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
26.7%
16/60 • Number of events 26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.3%
3/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.3%
2/24 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
13.0%
3/23 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.7%
4/60 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.7%
3/45 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
5.0%
3/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.8%
3/16 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
17.1%
7/41 • Number of events 12 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.6%
5/43 • Number of events 14 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.9%
4/45 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.6%
5/43 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.5%
3/26 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.8%
4/41 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
12.5%
3/24 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.7%
2/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.6%
8/43 • Number of events 8 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
17.8%
8/45 • Number of events 9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.5%
3/26 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
5.0%
3/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.7%
2/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
12.5%
2/16 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated myositis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.9%
4/45 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.5%
3/26 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
1/3 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
12.2%
5/41 • Number of events 8 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.9%
4/45 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of spleen
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic complication
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Anaesthesia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Brain fog
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
5/45 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.5%
3/26 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
10.0%
6/60 • Number of events 12 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
12.2%
5/41 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
17.1%
7/41 • Number of events 11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.7%
4/60 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Migraine
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Neuralgia
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
5.0%
3/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.6%
6/41 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
31.7%
19/60 • Number of events 31 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Psychiatric disorders
Fear of falling
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Psychiatric disorders
Frigophobia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.6%
6/41 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
5/45 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.3%
4/43 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.8%
4/41 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.3%
5/60 • Number of events 8 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.7%
2/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.3%
2/24 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.3%
2/24 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Renal and urinary disorders
Ureteric dilatation
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.7%
3/45 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
22.2%
2/9 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.6%
6/41 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.6%
5/43 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
15.6%
7/45 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.6%
5/43 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
26.9%
7/26 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
25.0%
6/24 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.7%
2/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.8%
3/16 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
17.1%
7/41 • Number of events 8 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.0%
6/43 • Number of events 8 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
5/45 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.7%
2/26 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.8%
4/41 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
5.0%
3/60 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
4/24 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.7%
2/23 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.9%
4/45 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.7%
2/23 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus inflammation
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.0%
6/43 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
21.7%
5/23 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.0%
3/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.7%
3/45 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.8%
4/41 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.3%
3/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
34.1%
14/41 • Number of events 14 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.6%
5/43 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
23.8%
5/21 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
1/9 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.4%
2/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.7%
4/60 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Immune-mediated dermatitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
21.7%
13/60 • Number of events 20 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.3%
2/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
12.5%
2/16 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.1%
1/11 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
43.9%
18/41 • Number of events 24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
23.3%
10/43 • Number of events 13 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
37.8%
17/45 • Number of events 29 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
20.9%
9/43 • Number of events 15 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
15.4%
4/26 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
23.8%
5/21 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
26.8%
11/41 • Number of events 15 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
21.7%
13/60 • Number of events 19 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
12.5%
3/24 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
30.4%
7/23 • Number of events 10 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.7%
2/23 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
25.0%
4/16 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
22.2%
2/9 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.2%
2/11 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
36.6%
15/41 • Number of events 36 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
41.9%
18/43 • Number of events 28 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
24.4%
11/45 • Number of events 19 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
18.6%
8/43 • Number of events 8 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
23.1%
6/26 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
33.3%
7/21 • Number of events 9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
22.0%
9/41 • Number of events 10 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
20.0%
12/60 • Number of events 15 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
9.5%
2/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
20.8%
5/24 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
21.7%
5/23 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
11.1%
5/45 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.7%
2/43 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.9%
2/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.7%
4/60 • Number of events 9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.2%
1/16 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
12.2%
5/41 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
5.0%
3/60 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Superficial inflammatory dermatosis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
6.7%
3/45 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Vascular disorders
Hot flush
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
22.2%
2/9 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.2%
1/45 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
7.7%
2/26 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
14.3%
3/21 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
8.3%
5/60 • Number of events 17 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.3%
1/43 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
2.4%
1/41 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
1.7%
1/60 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.2%
1/24 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Vascular disorders
Jugular vein embolism
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.3%
1/23 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Vascular disorders
Penetrating aortic ulcer
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
3.8%
1/26 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Vascular disorders
Scalp haematoma
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/16 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/9 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/11 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/45 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/43 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/26 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/41 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/60 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/24 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety set.
|
0.00%
0/23 • All cause-mortality data was collected from randomization through end of study (up to 5 years). SAEs & non-serious AEs data: up to 30 days after last dose of study drugs (Maximum time duration on study: up to 35.7 months (escalation cohort); up to 13.3 months (verification cohort); up to 41.6 months [Cohorts 1 to 9] & up to 21.4 months [Cohort 10])
Analysis was performed on safety 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