Trial Outcomes & Findings for A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Lung Cancer or Mesothelioma (Pegathor Lung 202) (NCT NCT04914897)

NCT ID: NCT04914897

Last Updated: 2025-10-02

Results Overview

ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. CR. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 millimeter (mm) (\<1 centimeter \[cm\]). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

106 participants

Primary outcome timeframe

From first dose of study treatment administration (Day 1) up to approximately 21 months

Results posted on

2025-10-02

Participant Flow

This study was conducted at 31 centers (corresponds to number of sites which screened at least one participant) in 11 countries. Out of 152 participants who were screened from 23 September 2021 to 07 October 2022, 106 participants were enrolled in the study and were assigned to 1 of the 4 cohorts (Cohorts A1, A2, B1, and C1) based on their disease type.

The study was terminated based on strategic sponsor decision not driven by any safety concerns. The Cohorts B2 and A3 were not initiated and no participants were enrolled. Note: Reason for not completed = Reason for permanent full intervention discontinuation.

Participant milestones

Participant milestones
Measure
Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
Participants with previously untreated Stage IV non-small cell lung cancer (NSCLC) and programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) of \>=50% were included in this cohort. Participants received pegenzileukin 24 microgram per kilogram (μg/kg) along with pembrolizumab 200 milligram (mg) via intravenous (IV) infusion over 30 minutes every 3 weeks (q3w) on Day 1 of each cycle (each cycle is 21 days) (as first-line \[1L\] therapy), until disease progression (PD), unacceptable adverse event (AE) or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
Participants with NSCLC for whom standard of care (SOC) was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as second-line or third-line \[2/3L\] therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort C1:Mesothelioma: Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Overall Study
STARTED
17
20
40
29
Overall Study
COMPLETED
5
1
1
0
Overall Study
NOT COMPLETED
12
19
39
29

Reasons for withdrawal

Reasons for withdrawal
Measure
Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
Participants with previously untreated Stage IV non-small cell lung cancer (NSCLC) and programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) of \>=50% were included in this cohort. Participants received pegenzileukin 24 microgram per kilogram (μg/kg) along with pembrolizumab 200 milligram (mg) via intravenous (IV) infusion over 30 minutes every 3 weeks (q3w) on Day 1 of each cycle (each cycle is 21 days) (as first-line \[1L\] therapy), until disease progression (PD), unacceptable adverse event (AE) or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
Participants with NSCLC for whom standard of care (SOC) was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as second-line or third-line \[2/3L\] therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort C1:Mesothelioma: Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Overall Study
Withdrawal by Subject
3
1
1
1
Overall Study
Poor compliance to protocol
0
0
1
0
Overall Study
Progressive disease
5
14
30
21
Overall Study
Adverse event: Not related to Coronavirus Disease 2019 (COVID-19)
3
4
7
6
Overall Study
Other
1
0
0
1

Baseline Characteristics

A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Lung Cancer or Mesothelioma (Pegathor Lung 202)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
n=17 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of \>=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
n=20 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
n=40 Participants
Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
n=29 Participants
Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Total
n=106 Participants
Total of all reporting groups
Age, Continuous
65.3 years
STANDARD_DEVIATION 10.4 • n=5 Participants
68.8 years
STANDARD_DEVIATION 8.4 • n=7 Participants
63.6 years
STANDARD_DEVIATION 11.6 • n=5 Participants
69.1 years
STANDARD_DEVIATION 10.7 • n=4 Participants
66.3 years
STANDARD_DEVIATION 10.8 • n=21 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
6 Participants
n=7 Participants
13 Participants
n=5 Participants
8 Participants
n=4 Participants
35 Participants
n=21 Participants
Sex: Female, Male
Male
9 Participants
n=5 Participants
14 Participants
n=7 Participants
27 Participants
n=5 Participants
21 Participants
n=4 Participants
71 Participants
n=21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
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
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
1 Participants
n=4 Participants
6 Participants
n=21 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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
Race (NIH/OMB)
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
Race (NIH/OMB)
White
16 Participants
n=5 Participants
18 Participants
n=7 Participants
32 Participants
n=5 Participants
12 Participants
n=4 Participants
78 Participants
n=21 Participants
Race (NIH/OMB)
More than one race
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
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
0 Participants
n=7 Participants
5 Participants
n=5 Participants
16 Participants
n=4 Participants
22 Participants
n=21 Participants

PRIMARY outcome

Timeframe: From first dose of study treatment administration (Day 1) up to approximately 21 months

Population: The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment.

ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. CR. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 millimeter (mm) (\<1 centimeter \[cm\]). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure
Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
n=17 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of \>=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
n=20 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohorts A1 and A2: Objective Response Rate (ORR)
41.2 percentage of participants
Interval 21.2 to 63.6
15.0 percentage of participants
Interval 4.2 to 34.4

PRIMARY outcome

Timeframe: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 14 months

Population: The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment.

ORR was defined as the percentage of participants who had a confirmed CR or PR as per RECIST v1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 mm (\<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure
Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
n=40 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of \>=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohorts B1: Objective Response Rate
2.5 percentage of participants
Interval 0.1 to 11.3

PRIMARY outcome

Timeframe: From first dose of study treatment administration (Day 1) up to approximately 21 months

Population: The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment.

ORR was defined as the percentage of participants who had a confirmed CR or PR assessed by the investigator as per modified RECIST (mRECIST) v1.1. CR. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 mm (\<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure
Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
n=29 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of \>=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohorts C1: Objective Response Rate
3.4 percentage of participants
Interval 0.2 to 15.3

SECONDARY outcome

Timeframe: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1)

Population: The exposed population consisted of all participants who had given their informed consent and received at least one dose of study treatment (pegenzileukin or other anticancer therapies).

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any AE that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened (according to the investigator's opinion) or became serious during the TE period.

Outcome measures

Outcome measures
Measure
Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
n=17 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of \>=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
n=20 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
n=40 Participants
Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
n=29 Participants
Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
16 Participants
20 Participants
40 Participants
29 Participants
All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
6 Participants
11 Participants
21 Participants
13 Participants

SECONDARY outcome

Timeframe: From Day 1 to Day 21 of Cycle 1 (each cycle is 21 days)

Population: The DLT-evaluable population consisted of all exposed participants in the safety run-in who had been observed for at least 21 days. Any participants who had experienced a DLT during DLT observation period were also DLT-evaluable.

Selected events that occurred during DLT observation period were considered as DLT unless due to PD or to a cause obviously unrelated to pegenzileukin. Selected events included: grade (G) 4 neutropenia for \>=7 consecutive days, G3 or 4 neutropenia complicated by fever or microbiologically or radiographically documented infection, G3 or 4 thrombocytopenia associated with clinically significant bleeding that required clinical intervention; G3 or above alanine aminotransferase or aspartate aminotransferase in combination with a bilirubin \>2 times upper limit of normal with no evidence of cholestasis or another cause such as viral infection or other drugs;G3 or above vascular leak syndrome, hypotension, and cytokine release syndrome;any other G3; G3 or 4 non-hematologic laboratory value; any death not clearly due to the underlying disease or extraneous causes;any toxicity that required permanent discontinuation of the study treatment(s).

Outcome measures

Outcome measures
Measure
Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
n=2 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of \>=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
n=1 Participants
Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
n=4 Participants
Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
All Cohorts: Number of Participants With Dose Limiting Toxicities (DLTs)
0 Participants
0 Participants
1 Participants
0 Participants

SECONDARY outcome

Timeframe: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 27 months (Cohorts A1 and A2), 14 months (Cohort B1), and 24 months (Cohort C1)

Population: The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment. Only participants with confirmed CR or PR were analyzed.

TTR was defined as the time from the date of first study treatment administration to the first tumor assessment at which the overall response was recorded as PR or CR that was subsequently confirmed as per RECIST v 1.1 (NSCLC) and assessed by the investigator as per mRECIST v1.1 (mesothelioma). CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 mm (\<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure
Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
n=7 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of \>=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
n=3 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
n=1 Participants
Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
n=1 Participants
Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
All Cohorts: Time to Response (TTR)
2.3 months
Standard Deviation 0.8
3.4 months
Standard Deviation 1.4
2.2 months
Standard Deviation NA
NA indicates that the standard deviation (SD) was not estimable for 1 participant.
4.1 months
Standard Deviation NA
NA indicates that the SD was not estimable for 1 participant.

SECONDARY outcome

Timeframe: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 27 months (Cohorts A1 and A2), 14 months (Cohort B1), and 24 months (Cohort C1)

Population: The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment. Only participants with confirmed CR or PR were analyzed.

DOR was defined as time from date of first tumor assessment at which overall response was recorded as CR or PR that was subsequently confirmed to date of first documentation of objective PD before initiation of any post-treatment anti-cancer therapy or death due to any cause, whichever occurred first, as per RECIST v 1.1 (NSCLS) and assessed by investigator as per mRECIST v1.1 (mesothelioma). CR: disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 mm (\<1 cm). PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. PD:at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this included baseline sum if that was smallest on study), in addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm (0.5 cm).

Outcome measures

Outcome measures
Measure
Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
n=7 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of \>=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
n=3 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
n=1 Participants
Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
n=1 Participants
Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
All Cohorts: Duration of Response (DOR)
NA months
Interval 5.8 to
NA indicates that the median and upper limit of 90% confidence interval (CI) were not estimable due to insufficient number of participants with events.
NA months
NA indicates that the median, lower limit, and upper limit of 90% CI were not estimable due to insufficient number of participants with events.
NA months
NA indicates that the median, lower limit, and upper limit of 90% CI were not estimable due to insufficient number of participants with events.
NA months
NA indicates that the median, lower limit, and upper limit of 90% CI were not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 27 months (Cohorts A1 and A2), 14 months (Cohort B1), and 24 months (Cohort C1)

Population: The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment.

The CBR was defined as the percentage of participants with clinical benefit: confirmed CR or PR as best overall response (BOR), or stable disease (SD) that lasted at least 6 months as per RECIST v 1.1 (NSCLS) and assessed by investigator as per mRECIST v1.1 (mesothelioma). CR: disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 mm (\<1 cm). PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. BOR was the best response observed from start of the study treatment until PD, death, cut-off date or initiation of post-treatment anticancer therapy, whichever occurred first. 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

Outcome measures
Measure
Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
n=17 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of \>=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
n=20 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
n=40 Participants
Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
n=29 Participants
Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
All Cohorts: Clinical Benefit Rate (CBR)
58.8 percentage of participants
Interval 36.4 to 78.8
30.0 percentage of participants
Interval 14.0 to 50.8
5.0 percentage of participants
Interval 0.9 to 14.9
10.3 percentage of participants
Interval 2.9 to 24.6

SECONDARY outcome

Timeframe: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 27 months (Cohorts A1 and A2), 14 months (Cohort B1), and 24 months (Cohort C1)

Population: The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment.

The PFS was defined as the time from the date of first study treatment to the date of the first documentation of objective PD, or death due to any cause, whichever occurred first as per RECIST v 1.1 (NSCLS) and assessed by investigator as per mRECIST v1.1 (mesothelioma). PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm (0.5 cm).

Outcome measures

Outcome measures
Measure
Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
n=17 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of \>=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
n=20 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
n=40 Participants
Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
n=29 Participants
Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
All Cohorts: Progression Free Survival (PFS)
10.3 months
Interval 4.2 to
NA indicates that the upper limit of 90% CI was not estimable due to insufficient number of participants with events.
3.9 months
Interval 2.1 to 8.7
2.1 months
Interval 1.9 to 4.1
2.3 months
Interval 2.1 to 4.0

SECONDARY outcome

Timeframe: Days 2 and 3 of Cycle 1 (each cycle is 21 days)

Population: The PK population consisted of all participants from exposed population with at least one PK concentration available after the first dose of study treatment. Only participants with data collected at specified timepoints are reported. Limited or no participants returned on the Cycle 1 Day 3 for sample collection.

Blood samples were collected at specified timepoints for the assessment of plasma concentrations of pegenzileukin. The pharmacokinetic (PK) parameters were calculated using non-compartmental method.

Outcome measures

Outcome measures
Measure
Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
n=15 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of \>=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
n=17 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
n=25 Participants
Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
n=22 Participants
Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
All Cohorts: Plasma Concentrations of Pegenzileukin
Day 2 Cycle 1
214.7 nanogram/milliliter (ng/mL)
Standard Deviation 81.8
227.6 nanogram/milliliter (ng/mL)
Standard Deviation 77.7
212.0 nanogram/milliliter (ng/mL)
Standard Deviation 63.9
200.8 nanogram/milliliter (ng/mL)
Standard Deviation 61.4
All Cohorts: Plasma Concentrations of Pegenzileukin
Day 3 Cycle 1
42.7 nanogram/milliliter (ng/mL)
Standard Deviation 14.8
121.0 nanogram/milliliter (ng/mL)
Standard Deviation NA
NA indicates that the SD was not estimable for 1 participant.
56.3 nanogram/milliliter (ng/mL)
Standard Deviation 12.7

SECONDARY outcome

Timeframe: Cycles 1, 2, 4, 7, 10, and 15 (each cycle is 21 days)

Population: The PK population consisted of all participants from exposed population with at least 1 PK concentration available after the first dose of study treatment. Only participants with data collected at specified timepoints are reported. Eventually, the participants discontinued as they progressed in the study. Hence, fewer participants at each cycle and no participants returned on Cycle 15 in Cohort B1 Arm.

Blood samples were collected at specified timepoints for the assessment of Ceoi of pegenzileukin.

Outcome measures

Outcome measures
Measure
Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
n=15 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of \>=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
n=15 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
n=33 Participants
Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
n=27 Participants
Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
All Cohorts: Concentration at End of Infusion (Ceoi) of Pegenzileukin
Cycle 7
509.3 ng/mL
Standard Deviation 103.9
554.3 ng/mL
Standard Deviation 129.3
590.3 ng/mL
Standard Deviation 234.0
486.5 ng/mL
Standard Deviation 251.3
All Cohorts: Concentration at End of Infusion (Ceoi) of Pegenzileukin
Cycle 10
412.5 ng/mL
Standard Deviation 109.4
483.0 ng/mL
Standard Deviation NA
NA indicates that the SD was not estimable for 1 participant.
152.0 ng/mL
Standard Deviation NA
NA indicates that the SD was not estimable for 1 participant.
443.0 ng/mL
Standard Deviation 169.0
All Cohorts: Concentration at End of Infusion (Ceoi) of Pegenzileukin
Cycle 4
403.7 ng/mL
Standard Deviation 122.6
413.9 ng/mL
Standard Deviation 103.9
507.1 ng/mL
Standard Deviation 168.6
400.4 ng/mL
Standard Deviation 125.8
All Cohorts: Concentration at End of Infusion (Ceoi) of Pegenzileukin
Cycle 15
352.0 ng/mL
Standard Deviation NA
NA indicates that the SD was not estimable for 1 participant.
265.0 ng/mL
Standard Deviation NA
NA indicates that the SD was not estimable for 1 participant.
567.0 ng/mL
Standard Deviation NA
NA indicates that the SD was not estimable for 1 participant.
All Cohorts: Concentration at End of Infusion (Ceoi) of Pegenzileukin
Cycle 1
510.2 ng/mL
Standard Deviation 164.1
434.1 ng/mL
Standard Deviation 232.2
535.8 ng/mL
Standard Deviation 402.6
457.0 ng/mL
Standard Deviation 140.9
All Cohorts: Concentration at End of Infusion (Ceoi) of Pegenzileukin
Cycle 2
445.8 ng/mL
Standard Deviation 90.6
418.7 ng/mL
Standard Deviation 215.3
585.6 ng/mL
Standard Deviation 496.9
442.0 ng/mL
Standard Deviation 131.7

SECONDARY outcome

Timeframe: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1)

Population: The ADA population consisted of all participants from the exposed population with at least one ADA result (positive, negative or inconclusive) after the first dose of study treatment.

Blood samples were collected at specified timepoints to assess the presence of ADAs against pegenzileukin. Treatment-emergent ADA was defined as at least one treatment-induced or treatment-boosted ADA. Treatment-induced ADA was defined as ADA that developed during the TE period and without pre-existing ADA (including participants without pre-treatment samples). Treatment-boosted ADA was defined as pre-existing ADA that was boosted during the TE period to a significant higher titer than the baseline. Number of participants with treatment-emergent ADA is presented.

Outcome measures

Outcome measures
Measure
Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
n=13 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of \>=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
n=9 Participants
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
n=18 Participants
Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
n=8 Participants
Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
All Cohorts: Number of Participants With Anti-Drug Antibodies (ADAs) Against Pegenzileukin
0 Participants
0 Participants
2 Participants
0 Participants

Adverse Events

Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy

Serious events: 6 serious events
Other events: 16 other events
Deaths: 3 deaths

Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy

Serious events: 11 serious events
Other events: 18 other events
Deaths: 13 deaths

Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy

Serious events: 21 serious events
Other events: 38 other events
Deaths: 26 deaths

Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy

Serious events: 13 serious events
Other events: 27 other events
Deaths: 18 deaths

Serious adverse events

Serious adverse events
Measure
Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
n=17 participants at risk
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of \>=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
n=20 participants at risk
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
n=40 participants at risk
Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
n=29 participants at risk
Participants with mesothelioma who had no SOC established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Infections and infestations
Covid-19
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Infections and infestations
Infection
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Infections and infestations
Oesophageal Candidiasis
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Infections and infestations
Pleural Infection Bacterial
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Infections and infestations
Pneumonia
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Infections and infestations
Septic Shock
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Infections and infestations
Urosepsis
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Blood and lymphatic system disorders
Anaemia
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Blood and lymphatic system disorders
Immune Thrombocytopenia
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Immune system disorders
Cytokine Release Syndrome
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
15.0%
3/20 • Number of events 4 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
17.5%
7/40 • Number of events 11 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
10.3%
3/29 • Number of events 3 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Immune system disorders
Drug Hypersensitivity
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Endocrine disorders
Adrenal Insufficiency
5.9%
1/17 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Psychiatric disorders
Delirium
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Nervous system disorders
Brain Oedema
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Nervous system disorders
Cerebrovascular Accident
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Nervous system disorders
Dysarthria
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Nervous system disorders
Haemorrhage Intracranial
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Nervous system disorders
Hemiparaesthesia
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Nervous system disorders
Hepatic Encephalopathy
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Nervous system disorders
Ischaemic Stroke
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
6.9%
2/29 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Nervous system disorders
Seizure
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Nervous system disorders
Transient Ischaemic Attack
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Cardiac disorders
Acute Coronary Syndrome
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Cardiac disorders
Cardiac Failure Acute
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Cardiac disorders
Immune-Mediated Myocarditis
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Cardiac disorders
Myocardial Infarction
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Vascular disorders
Capillary Leak Syndrome
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Vascular disorders
Hypertension
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
2/40 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
5.9%
1/17 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
10.3%
3/29 • Number of events 4 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders
Pleurisy
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Gastrointestinal disorders
Ascites
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Gastrointestinal disorders
Diarrhoea
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Gastrointestinal disorders
Immune-Mediated Enterocolitis
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Gastrointestinal disorders
Immune-Mediated Pancreatitis
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Gastrointestinal disorders
Malignant Ascites
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
6.9%
2/29 • Number of events 3 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Hepatobiliary disorders
Hepatitis
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Renal and urinary disorders
Nephritis
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Reproductive system and breast disorders
Scrotal Oedema
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
General disorders
Asthenia
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
General disorders
Disease Progression
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
General disorders
General Physical Health Deterioration
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
General disorders
Multiple Organ Dysfunction Syndrome
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
General disorders
Oedema Peripheral
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
General disorders
Pain
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Injury, poisoning and procedural complications
Infusion Related Reaction
11.8%
2/17 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
2/40 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.

Other adverse events

Other adverse events
Measure
Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
n=17 participants at risk
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of \>=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
n=20 participants at risk
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
n=40 participants at risk
Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
n=29 participants at risk
Participants with mesothelioma who had no SOC established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Infections and infestations
Bronchitis
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Infections and infestations
Covid-19
29.4%
5/17 • Number of events 5 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
17.5%
7/40 • Number of events 7 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Infections and infestations
Cystitis
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Infections and infestations
Nasopharyngitis
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Infections and infestations
Oral Fungal Infection
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
6.9%
2/29 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Infections and infestations
Oral Infection
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Infections and infestations
Pharyngitis
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Infections and infestations
Pneumonia
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Infections and infestations
Sinusitis
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Infections and infestations
Urinary Tract Infection
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Infections and infestations
Vascular Device Infection
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
6.9%
2/29 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Blood and lymphatic system disorders
Anaemia
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Immune system disorders
Cytokine Release Syndrome
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
15.0%
3/20 • Number of events 3 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
10.0%
4/40 • Number of events 10 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
10.3%
3/29 • Number of events 7 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Endocrine disorders
Hyperthyroidism
17.6%
3/17 • Number of events 3 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Endocrine disorders
Hypothyroidism
11.8%
2/17 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Endocrine disorders
Immune-Mediated Hypophysitis
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Endocrine disorders
Immune-Mediated Hypothyroidism
11.8%
2/17 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Metabolism and nutrition disorders
Decreased Appetite
17.6%
3/17 • Number of events 3 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
20.0%
4/20 • Number of events 5 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
15.0%
6/40 • Number of events 6 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
31.0%
9/29 • Number of events 9 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Metabolism and nutrition disorders
Dehydration
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
10.0%
2/20 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Metabolism and nutrition disorders
Hyperglycaemia
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
6.9%
2/29 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Psychiatric disorders
Anxiety Disorder
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Psychiatric disorders
Insomnia
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
6.9%
2/29 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Nervous system disorders
Dizziness
5.9%
1/17 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Nervous system disorders
Headache
17.6%
3/17 • Number of events 4 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
17.2%
5/29 • Number of events 6 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Nervous system disorders
Neuralgia
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Nervous system disorders
Paraesthesia
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Nervous system disorders
Sleep Deficit
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Nervous system disorders
Trigeminal Neuralgia
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Eye disorders
Cataract
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Eye disorders
Periorbital Oedema
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
2/40 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Cardiac disorders
Palpitations
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Cardiac disorders
Tachycardia
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Vascular disorders
Hypertension
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
13.8%
4/29 • Number of events 4 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Vascular disorders
Hypotension
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
6.9%
2/29 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders
Cough
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
10.0%
4/40 • Number of events 5 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
13.8%
4/29 • Number of events 4 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
11.8%
2/17 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
12.5%
5/40 • Number of events 5 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
13.8%
4/29 • Number of events 4 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
6.9%
2/29 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
6.9%
2/29 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Gastrointestinal disorders
Abdominal Pain
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
10.0%
2/20 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Gastrointestinal disorders
Abdominal Pain Upper
11.8%
2/17 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Gastrointestinal disorders
Constipation
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
17.2%
5/29 • Number of events 6 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Gastrointestinal disorders
Diarrhoea
35.3%
6/17 • Number of events 10 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
10.0%
2/20 • Number of events 4 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
2/40 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
13.8%
4/29 • Number of events 6 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Gastrointestinal disorders
Nausea
35.3%
6/17 • Number of events 8 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
15.0%
3/20 • Number of events 3 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
15.0%
6/40 • Number of events 7 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
20.7%
6/29 • Number of events 6 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Gastrointestinal disorders
Stomatitis
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
6.9%
2/29 • Number of events 4 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Gastrointestinal disorders
Vomiting
17.6%
3/17 • Number of events 5 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
12.5%
5/40 • Number of events 5 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
13.8%
4/29 • Number of events 7 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Hepatobiliary disorders
Hepatic Cytolysis
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
6.9%
2/29 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Hepatobiliary disorders
Hepatitis
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Hepatobiliary disorders
Hypertransaminasaemia
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
10.0%
2/20 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Skin and subcutaneous tissue disorders
Dry Skin
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
2/40 • Number of events 3 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Skin and subcutaneous tissue disorders
Immune-Mediated Dermatitis
5.9%
1/17 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Skin and subcutaneous tissue disorders
Night Sweats
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Skin and subcutaneous tissue disorders
Pruritus
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
10.0%
2/20 • Number of events 3 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
2/40 • Number of events 3 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
24.1%
7/29 • Number of events 7 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Skin and subcutaneous tissue disorders
Rash
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
10.0%
2/20 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
10.0%
4/40 • Number of events 7 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
6.9%
2/29 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Musculoskeletal and connective tissue disorders
Arthralgia
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
12.5%
5/40 • Number of events 7 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
13.8%
4/29 • Number of events 7 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Musculoskeletal and connective tissue disorders
Back Pain
11.8%
2/17 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
7.5%
3/40 • Number of events 3 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
20.7%
6/29 • Number of events 6 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Musculoskeletal and connective tissue disorders
Bone Pain
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Musculoskeletal and connective tissue disorders
Myalgia
11.8%
2/17 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Musculoskeletal and connective tissue disorders
Neck Pain
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
6.9%
2/29 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Musculoskeletal and connective tissue disorders
Pain In Extremity
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Musculoskeletal and connective tissue disorders
Sacral Pain
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
General disorders
Asthenia
41.2%
7/17 • Number of events 11 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
10.0%
2/20 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
32.5%
13/40 • Number of events 13 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
51.7%
15/29 • Number of events 17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
General disorders
Chills
11.8%
2/17 • Number of events 4 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
General disorders
Fatigue
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
20.7%
6/29 • Number of events 7 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
General disorders
Feeling Hot
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
General disorders
Influenza Like Illness
11.8%
2/17 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
2/40 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
General disorders
Lithiasis
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
General disorders
Non-Cardiac Chest Pain
11.8%
2/17 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
10.3%
3/29 • Number of events 3 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
General disorders
Oedema
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
General disorders
Oedema Peripheral
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
General disorders
Pyrexia
17.6%
3/17 • Number of events 3 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
2/40 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
13.8%
4/29 • Number of events 4 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
General disorders
Xerosis
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
10.3%
3/29 • Number of events 3 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Investigations
Amylase Increased
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
3.4%
1/29 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Investigations
Blood Bilirubin Increased
0.00%
0/17 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
10.0%
2/20 • Number of events 3 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Investigations
Blood Magnesium Increased
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/40 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Investigations
Blood Thyroid Stimulating Hormone Increased
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/29 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Investigations
Lipase Increased
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
0.00%
0/20 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
2.5%
1/40 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
6.9%
2/29 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Investigations
Weight Decreased
5.9%
1/17 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
5.0%
1/20 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
7.5%
3/40 • Number of events 3 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
6.9%
2/29 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
Injury, poisoning and procedural complications
Infusion Related Reaction
58.8%
10/17 • Number of events 72 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
35.0%
7/20 • Number of events 45 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
47.5%
19/40 • Number of events 39 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.
72.4%
21/29 • Number of events 75 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Analysis was performed on the exposed population.

Additional Information

Trial Transparency Team

Sanofi aventis recherche & développement

Phone: 800-633-1610

Results disclosure agreements

  • Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
  • Publication restrictions are in place

Restriction type: OTHER