Trial Outcomes & Findings for A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201) (NCT NCT04913220)
NCT ID: NCT04913220
Last Updated: 2026-02-04
Results Overview
The ORR was defined as the percentage of participants who had best overall response (BOR) as confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or modified world health organization (WHO) response criteria. 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
PHASE1/PHASE2
Target enrollment
46 participants
Primary outcome timeframe
From first dose of study treatment administration (Day 1) up to approximately 25 months (Cohorts A and B)
Results posted on
2026-02-04
Participant Flow
This study was conducted at 21 centers (corresponds to number of sites which screened at least one participant) in 7 countries. Out of 61 participants who were screened from 15 July 2021 to 25 October 2022, 46 participants were enrolled in the study.
The study was terminated based on strategic sponsor decision not driven by any safety concerns. Note: Reason for not completed = Reason for permanent full intervention discontinuation.
Participant milestones
| Measure |
Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
Participants who were immune checkpoint inhibitor (ICI)- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 microgram per kilogram (mcg/kg) along with cemiplimab 350 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 A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 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 B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
Participants with ICI-naïve, metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as first to third line \[1-3L\] therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
7
|
16
|
3
|
|
Overall Study
COMPLETED
|
4
|
2
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
16
|
5
|
12
|
3
|
Reasons for withdrawal
| Measure |
Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
Participants who were immune checkpoint inhibitor (ICI)- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 microgram per kilogram (mcg/kg) along with cemiplimab 350 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 A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 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 B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
Participants with ICI-naïve, metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as first to third line \[1-3L\] therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
|---|---|---|---|---|
|
Overall Study
Not Related to Coronavirus Disease 2019 (COVID-19)
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
0
|
|
Overall Study
Poor Compliance to Protocol
|
0
|
0
|
1
|
0
|
|
Overall Study
Progressive Disease
|
8
|
4
|
3
|
2
|
|
Overall Study
Adverse event: Not related to COVID-19
|
7
|
1
|
4
|
1
|
Baseline Characteristics
A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)
Baseline characteristics by cohort
| Measure |
Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=20 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 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 A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=7 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 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 B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=16 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=3 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 11.7 • n=41 Participants
|
56.1 years
STANDARD_DEVIATION 12.9 • n=1581 Participants
|
69.8 years
STANDARD_DEVIATION 14.3 • n=4626 Participants
|
74.0 years
STANDARD_DEVIATION 21.0 • n=72 Participants
|
64.2 years
STANDARD_DEVIATION 14.1 • n=11 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
15 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
11 Participants
n=4626 Participants
|
3 Participants
n=72 Participants
|
31 Participants
n=11 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=41 Participants
|
6 Participants
n=1581 Participants
|
13 Participants
n=4626 Participants
|
2 Participants
n=72 Participants
|
41 Participants
n=11 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
5 Participants
n=11 Participants
|
PRIMARY outcome
Timeframe: From first dose of study treatment administration (Day 1) up to approximately 25 months (Cohorts A and B)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 ORR was defined as the percentage of participants who had best overall response (BOR) as confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or modified world health organization (WHO) response criteria. 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
| Measure |
Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=20 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 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 A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=7 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 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 B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=16 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=3 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
|---|---|---|---|---|
|
All Cohorts: Objective Response Rate (ORR)
|
40.0 Percentage of participants
Interval 21.7 to 60.6
|
57.1 Percentage of participants
Interval 22.5 to 87.1
|
56.3 Percentage of participants
Interval 33.3 to 77.3
|
0 Percentage of participants
Interval 0.0 to 63.2
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B)Population: The exposed population consisted of all participants who had given their informed consent and received at least one dose of study treatment.
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
| Measure |
Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=20 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 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 A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=7 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 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 B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=16 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=3 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L 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
|
20 Participants
|
7 Participants
|
16 Participants
|
3 Participants
|
|
All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
11 Participants
|
4 Participants
|
8 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 21 of Cycle 1 (each cycle is 21 days: Cohorts A and B)Population: The DLT-evaluable population consisted of all exposed participants in the dose escalation who had been treated and 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 the DLT observation period were considered as DLT unless due to PD or to a cause obviously unrelated to pegenzileukin. Selected events included: any grade 4 neutropenia irrespective of duration; any febrile neutropenia; grade 3 thrombocytopenia associated with transfusion in addition to bleeding and any grade 4 thrombocytopenia; grade 3 or above: alanine aminotransferase or aspartate aminotransferase, vascular leak syndrome, hypotension, cytokine release syndrome, and AE that did not resolve to grade \<=2 within 7 days of starting accepted standard of care medical management; and grade 4 laboratory abnormalities.
Outcome measures
| Measure |
Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=5 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 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 A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=7 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 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 B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=4 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=3 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L 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)
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B)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 CR rate was defined as the percentage of participants who had a confirmed CR as per RECIST v 1.1 or modified WHO response criteria. 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).
Outcome measures
| Measure |
Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=20 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 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 A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=7 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 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 B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=16 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=3 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
|---|---|---|---|---|
|
All Cohorts: Complete Response (CR) Rate
|
5.0 Percentage of participants
Interval 0.3 to 21.6
|
14.3 Percentage of participants
Interval 0.7 to 52.1
|
0 Percentage of participants
Interval 0.0 to 17.1
|
0 Percentage of participants
Interval 0.0 to 63.2
|
SECONDARY outcome
Timeframe: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B)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 were analyzed.
The time to CR was defined as the time from the first administration of study treatment to the first tumor assessment at which the overall response was recorded as CR that was subsequently confirmed as per RECIST v 1.1 or modified WHO response criteria. 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).
Outcome measures
| Measure |
Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=1 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 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 A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=1 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 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 B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
|---|---|---|---|---|
|
All Cohorts: Time to Complete Response
|
4.0 Months
Interval 4.0 to 4.0
|
4.0 Months
Interval 4.0 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B)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.
The TTR was defined as the time from the 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 or modified WHO response criteria. 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
| Measure |
Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=8 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 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 A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=4 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 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 B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=9 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
|---|---|---|---|---|
|
All Cohorts: Time to Response (TTR)
|
2.1 Months
Interval 2.0 to 6.0
|
2.1 Months
Interval 2.0 to 4.0
|
2.8 Months
Interval 2.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B)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.
The DOR was defined as the time from the first tumor assessment at which the overall response was recorded as CR or PR that was subsequently confirmed until documented PD before the initiation of any subsequent anti-cancer therapy or death due to any cause, whichever occurred first, as per RECIST v 1.1 or modified WHO response criteria. 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. 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
| Measure |
Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=8 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 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 A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=4 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 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 B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=9 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L 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 8.5 to
NA indicates that the median and upper limit of 90% confidence interval (CI) was not estimable due to insufficient number of participants with events.
|
NA Months
Interval 4.2 to
NA indicates that the median and upper limit of 90% CI was not estimable due to insufficient number of participants with events.
|
NA Months
Interval 4.1 to
NA indicates that the median and upper limit of 90% CI was 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 26 months (Cohorts A and B)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 BOR, or stable disease (SD) lasting at least 6 months, as per RECIST v 1.1 or modified WHO response criteria. 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. BOR was defined as the best response observed from the start of the study treatment until PD, death, cut-off date or initiation of post-treatment anti-cancer 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
| Measure |
Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=20 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 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 A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=7 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 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 B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=16 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=3 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
|---|---|---|---|---|
|
All Cohorts: Clinical Benefit Rate (CBR)
|
40.0 Percentage of participants
Interval 21.7 to 60.6
|
57.1 Percentage of participants
Interval 22.5 to 87.1
|
56.3 Percentage of participants
Interval 33.3 to 77.3
|
0 Percentage of participants
Interval 0.0 to 63.2
|
SECONDARY outcome
Timeframe: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B)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 administration 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 or modified WHO response criteria. 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
| Measure |
Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=20 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 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 A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=7 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 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 B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=16 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=3 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
|---|---|---|---|---|
|
All Cohorts: Progression Free Survival (PFS)
|
6.2 Months
Interval 2.1 to
NA indicates that the upper limit of 90% CI was not estimable due to insufficient number of participants with events.
|
6.2 Months
Interval 2.0 to
NA indicates that the upper limit of 90% CI was not estimable due to insufficient number of participants with events.
|
NA Months
Interval 4.1 to
NA indicates that the median and upper limit of 90% CI were not estimable due to insufficient number of participants with events.
|
4.2 Months
Interval 4.1 to
NA indicates that the upper limit of 90% CI was not estimable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Cycle 1 Days 2 and 3 (each cycle is 21 days)Population: The pharmacokinetic (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.
Blood samples were collected at specified timepoints for the assessment of plasma concentrations of pegenzileukin.
Outcome measures
| Measure |
Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=20 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 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 A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=7 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 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 B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=14 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=2 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
|---|---|---|---|---|
|
All Cohorts: Plasma Concentrations of Pegenzileukin
Cycle 1 Day 2
|
114.6 Nanograms per milliliter (ng/mL)
Standard Deviation 48.7
|
209.4 Nanograms per milliliter (ng/mL)
Standard Deviation 58.3
|
105.2 Nanograms per milliliter (ng/mL)
Standard Deviation 33.8
|
137.0 Nanograms per milliliter (ng/mL)
Standard Deviation 15.6
|
|
All Cohorts: Plasma Concentrations of Pegenzileukin
Cycle 1 Day 3
|
26.1 Nanograms per milliliter (ng/mL)
Standard Deviation 13.8
|
74.4 Nanograms per milliliter (ng/mL)
Standard Deviation 22.0
|
31.1 Nanograms per milliliter (ng/mL)
Standard Deviation 11.3
|
61.4 Nanograms per milliliter (ng/mL)
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B)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
| Measure |
Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=20 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 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 A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=7 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 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 B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=12 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=3 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L 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
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycles 1, 2, 4, 7, 10, and 15 (each cycle is 21 days)Population: Eventually, the participants discontinued as they progressed in the study. Hence, fewer participants at each cycle and no participants returned i.e. no sample was collected for Cycle 10 for Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab and Cycle 15 for Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab and Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab.
Blood samples were collected at specified timepoints for the assessment of Ctrough of cemiplimab. 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.
Outcome measures
| Measure |
Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=19 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 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 A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=7 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 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 B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=14 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=3 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
|---|---|---|---|---|
|
All Cohorts: Concentration Observed Just Before Study Treatment Administration During Repeated Dosing (Ctrough) of Cemiplimab
Cycle 1
|
47.6 ng/mL
Standard Deviation 207.6
|
901.4 ng/mL
Standard Deviation 1965.0
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
Standard Deviation 0.0
|
|
All Cohorts: Concentration Observed Just Before Study Treatment Administration During Repeated Dosing (Ctrough) of Cemiplimab
Cycle 2
|
14368.0 ng/mL
Standard Deviation 4519.9
|
20685.7 ng/mL
Standard Deviation 8170.6
|
24215.8 ng/mL
Standard Deviation 30639.3
|
24200.0 ng/mL
Standard Deviation 12445.1
|
|
All Cohorts: Concentration Observed Just Before Study Treatment Administration During Repeated Dosing (Ctrough) of Cemiplimab
Cycle 4
|
37028.0 ng/mL
Standard Deviation 26202.1
|
43383.3 ng/mL
Standard Deviation 19397.5
|
37112.5 ng/mL
Standard Deviation 19946.6
|
8310.0 ng/mL
Standard Deviation NA
NA indicates that the standard deviation (SD) was not estimable for 1 participant.
|
|
All Cohorts: Concentration Observed Just Before Study Treatment Administration During Repeated Dosing (Ctrough) of Cemiplimab
Cycle 7
|
47333.3 ng/mL
Standard Deviation 24339.5
|
59500.0 ng/mL
Standard Deviation 30389.6
|
50825.0 ng/mL
Standard Deviation 12601.7
|
23500.0 ng/mL
Standard Deviation NA
NA indicates that the SD was not estimable for 1 participant.
|
|
All Cohorts: Concentration Observed Just Before Study Treatment Administration During Repeated Dosing (Ctrough) of Cemiplimab
Cycle 10
|
40300.0 ng/mL
Standard Deviation 1697.1
|
55933.3 ng/mL
Standard Deviation 17201.6
|
67050.0 ng/mL
Standard Deviation 22657.2
|
—
|
|
All Cohorts: Concentration Observed Just Before Study Treatment Administration During Repeated Dosing (Ctrough) of Cemiplimab
Cycle 15
|
45900.0 ng/mL
Standard Deviation NA
NA indicates that the SD was not estimable for 1 participant.
|
—
|
58075.0 ng/mL
Standard Deviation 15320.0
|
—
|
SECONDARY outcome
Timeframe: Cycles 1, 2, 4, 7, 10, and 15 (each cycle is 21 days)Population: Eventually, the participants discontinued as they progressed in the study. Hence, fewer participants at each cycle and no participants returned i.e. no sample was collected for Cycle 10 for Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab and Cycle 15 for Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab and Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab.
Blood samples were collected at specified timepoints for the assessment of Ceoi of cemiplimab. 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.
Outcome measures
| Measure |
Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=19 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 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 A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=7 Participants
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 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 B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=14 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=2 Participants
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L 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 Cemiplimab
Cycle 2
|
98026.7 ng/mL
Standard Deviation 15015.6
|
56142.9 ng/mL
Standard Deviation 31838.5
|
108025.0 ng/mL
Standard Deviation 30238.6
|
143500.0 ng/mL
Standard Deviation 707.1
|
|
All Cohorts: Concentration at End of Infusion (Ceoi) of Cemiplimab
Cycle 1
|
73494.7 ng/mL
Standard Deviation 34263.7
|
90500.0 ng/mL
Standard Deviation 32177.0
|
83857.1 ng/mL
Standard Deviation 29231.3
|
92550.0 ng/mL
Standard Deviation 9970.2
|
|
All Cohorts: Concentration at End of Infusion (Ceoi) of Cemiplimab
Cycle 4
|
107670.0 ng/mL
Standard Deviation 45761.5
|
93683.3 ng/mL
Standard Deviation 34262.9
|
130487.5 ng/mL
Standard Deviation 46562.0
|
113000.0 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 Cemiplimab
Cycle 7
|
108833.3 ng/mL
Standard Deviation 20336.7
|
125260.0 ng/mL
Standard Deviation 38195.4
|
149000.0 ng/mL
Standard Deviation 28248.9
|
137000.0 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 Cemiplimab
Cycle 10
|
121500.0 ng/mL
Standard Deviation 6364.0
|
91166.7 ng/mL
Standard Deviation 29458.8
|
171000.0 ng/mL
Standard Deviation 48996.6
|
—
|
|
All Cohorts: Concentration at End of Infusion (Ceoi) of Cemiplimab
Cycle 15
|
129000.0 ng/mL
Standard Deviation NA
NA indicates that the SD was not estimable for 1 participant.
|
—
|
159250.0 ng/mL
Standard Deviation 17231.3
|
—
|
Adverse Events
Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
Serious events: 11 serious events
Other events: 19 other events
Deaths: 5 deaths
Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
Serious events: 4 serious events
Other events: 7 other events
Deaths: 2 deaths
Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
Serious events: 8 serious events
Other events: 16 other events
Deaths: 2 deaths
Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=20 participants at risk
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 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 A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=7 participants at risk
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 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 B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=16 participants at risk
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=3 participants at risk
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
|---|---|---|---|---|
|
Infections and infestations
Abdominal Infection
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Infections and infestations
Abdominal Sepsis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Infections and infestations
Covid-19
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Immune system disorders
Cytokine Release Syndrome
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
42.9%
3/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Endocrine disorders
Immune-Mediated Adrenal Insufficiency
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Metabolism and nutrition disorders
Type 1 Diabetes Mellitus
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Nervous system disorders
Meningoradiculitis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Nervous system disorders
Myasthenic Syndrome
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Eye disorders
Visual Acuity Reduced
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Cardiac disorders
Cardiogenic Shock
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Cardiac disorders
Immune-Mediated Myocarditis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Gastrointestinal disorders
Gastric Antral Vascular Ectasia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Gastrointestinal disorders
Immune-Mediated Enterocolitis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Hepatobiliary disorders
Autoimmune Hepatitis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Hepatobiliary disorders
Immune-Mediated Hepatitis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Skin and subcutaneous tissue disorders
Skin Induration
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Musculoskeletal and connective tissue disorders
Immune-Mediated Myositis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Renal and urinary disorders
Prerenal Failure
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
General disorders
Pyrexia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Lymphocyte Count Decreased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
12.5%
2/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
33.3%
1/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
Other adverse events
| Measure |
Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=20 participants at risk
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 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 A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=7 participants at risk
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 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 B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab
n=16 participants at risk
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab
n=3 participants at risk
Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
|
|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
12.5%
2/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Infections and infestations
Covid-19
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
33.3%
1/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Infections and infestations
Cellulitis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Infections and infestations
Herpes Zoster
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Infections and infestations
Influenza
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Infections and infestations
Nasopharyngitis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
28.6%
2/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Infections and infestations
Onychomycosis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Infections and infestations
Oral Herpes
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Infections and infestations
Pharyngitis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Infections and infestations
Postoperative Wound Infection
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Infections and infestations
Sinusitis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Infections and infestations
Skin Infection
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Infections and infestations
Superinfection
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Infections and infestations
Suspected Covid-19
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
12.5%
2/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Infections and infestations
Urinary Tract Infection
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected Neoplasm
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
33.3%
1/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Haemorrhage
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Endocrine disorders
Hypothyroidism
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
33.3%
1/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Blood and lymphatic system disorders
Anaemia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
12.5%
2/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Immune system disorders
Cytokine Release Syndrome
|
15.0%
3/20 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
12.5%
2/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
33.3%
1/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Endocrine disorders
Glucocorticoid Deficiency
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Endocrine disorders
Hyperadrenocorticism
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Endocrine disorders
Hyperthyroidism
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
33.3%
1/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Endocrine disorders
Immune-Mediated Adrenal Insufficiency
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Endocrine disorders
Immune-Mediated Hyperthyroidism
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Endocrine disorders
Immune-Mediated Hypothyroidism
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Endocrine disorders
Thyroiditis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
15.0%
3/20 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
18.8%
3/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
12.5%
2/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
12.5%
2/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
12.5%
2/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Psychiatric disorders
Anxiety
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Psychiatric disorders
Confusional State
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Psychiatric disorders
Delirium
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
33.3%
1/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Psychiatric disorders
Depressed Mood
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Psychiatric disorders
Depression
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Psychiatric disorders
Insomnia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
12.5%
2/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Nervous system disorders
Ageusia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Nervous system disorders
Dizziness
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
18.8%
3/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Nervous system disorders
Dysgeusia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Nervous system disorders
Headache
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
12.5%
2/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Nervous system disorders
Immune-Mediated Neuropathy
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Nervous system disorders
Parkinsonism
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
12.5%
2/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Nervous system disorders
Tension Headache
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
33.3%
1/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Eye disorders
Acute Macular Neuroretinopathy
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Eye disorders
Cataract
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Eye disorders
Eye Pain
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Eye disorders
Vision Blurred
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Ear and labyrinth disorders
Deafness
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Ear and labyrinth disorders
Ear Pain
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Cardiac disorders
Cardiac Failure
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Cardiac disorders
Sinus Tachycardia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
33.3%
1/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Cardiac disorders
Tachycardia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Vascular disorders
Deep Vein Thrombosis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Vascular disorders
Hypertension
|
25.0%
5/20 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
18.8%
3/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
33.3%
1/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Vascular disorders
Systolic Hypertension
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
12.5%
2/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-Mediated Lung Disease
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Polyp
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.0%
1/20 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Gastrointestinal disorders
Colitis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
33.3%
1/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Gastrointestinal disorders
Constipation
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
5/20 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
28.6%
2/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
18.8%
3/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
33.3%
1/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Gastrointestinal disorders
Dry Mouth
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Gastrointestinal disorders
Dyspepsia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Gastrointestinal disorders
Dysphagia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Gastrointestinal disorders
Faecaloma
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Gastrointestinal disorders
Gastritis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Gastrointestinal disorders
Nausea
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
28.6%
2/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
25.0%
4/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Gastrointestinal disorders
Stomatitis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
31.2%
5/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Gastrointestinal disorders
Vomiting
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Hepatobiliary disorders
Hepatitis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Hepatobiliary disorders
Immune-Mediated Hepatitis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
12.5%
2/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Skin and subcutaneous tissue disorders
Erythema Nodosum
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Skin and subcutaneous tissue disorders
Immune-Mediated Dermatitis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.0%
6/20 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
25.0%
4/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
33.3%
1/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
12.5%
2/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
33.3%
1/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
28.6%
2/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
18.8%
3/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
12.5%
2/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Musculoskeletal and connective tissue disorders
Immune-Mediated Arthritis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.0%
3/20 • Number of events 12 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Necrosis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Renal and urinary disorders
Nocturia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
General disorders
Asthenia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
57.1%
4/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
12.5%
2/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
33.3%
1/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
General disorders
Chills
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
General disorders
Facial Pain
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
General disorders
Fatigue
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
37.5%
6/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
33.3%
1/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
General disorders
Influenza Like Illness
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
42.9%
3/7 • Number of events 16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
General disorders
Pyrexia
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
General disorders
Xerosis
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
31.2%
5/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
33.3%
1/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Alanine Aminotransferase Increased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
28.6%
2/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
12.5%
2/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Amylase Increased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Aspartate Aminotransferase Increased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
28.6%
2/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Blood Albumin Decreased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Blood Bilirubin Increased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
28.6%
2/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Blood Calcium Decreased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Blood Chloride Increased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
33.3%
1/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Blood Creatinine Increased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Blood Magnesium Decreased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Blood Phosphorus Decreased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Blood Triglycerides Increased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Blood Urea Increased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
C-Reactive Protein Increased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Cortisol Decreased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Haemoglobin Decreased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Lipase Increased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
12.5%
2/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Procalcitonin Increased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Protein Total Decreased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Prothrombin Time Prolonged
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Investigations
Weight Decreased
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
28.6%
2/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
18.8%
3/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
33.3%
1/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Injury, poisoning and procedural complications
Contusion
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Injury, poisoning and procedural complications
Fall
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
65.0%
13/20 • Number of events 53 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
71.4%
5/7 • Number of events 12 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
87.5%
14/16 • Number of events 86 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
66.7%
2/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Injury, poisoning and procedural complications
Skin Injury
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
14.3%
1/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/16 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/7 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
6.2%
1/16 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
0.00%
0/3 • 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 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed population.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Phone: 800-633-1610
Email: [email protected]
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