NCT04914897 · ADVERSE EVENTS

Adverse events

A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Lung Cancer or Mesothelioma (Pegathor Lung 202) · Source last updated 2025-10-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.
Other-event reporting threshold: 5%

Analysis was performed on the exposed population.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of \>=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.	6 / 17	16 / 17	3 / 17
Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.	11 / 20	18 / 20	13 / 20
Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.	21 / 40	38 / 40	26 / 40
Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy Participants with mesothelioma who had no SOC established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.	13 / 29	27 / 29	18 / 29

Group identifiers: EG000: Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy · EG001: Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy · EG002: Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy · EG003: Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
0
num At Risk
17
num Events
0
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
1
num At Risk
40
num Events
1
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Covid-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
0
num At Risk
17
num Events
0
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
1
num At Risk
29
num Events
1
term
Oesophageal Candidiasis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
0
num At Risk
17
num Events
0
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
1
num At Risk
29
num Events
1
term
Pleural Infection Bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
0
num At Risk
17
num Events
0
group Id
EG001
num Affected
1
num At Risk
20
num Events
1
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
0
num At Risk
17
num Events
0
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
1
num At Risk
40
num Events
1
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Septic Shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Urosepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
0
num At Risk
17
num Events
0
group Id
EG001
num Affected
1
num At Risk
20
num Events
1
group Id
EG002
num Affected
1
num At Risk
40
num Events
1
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
0
num At Risk
17
num Events
0
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
1
num At Risk
29
num Events
1
term
Immune Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
0
num At Risk
17
num Events
0
group Id
EG001
num Affected
3
num At Risk
20
num Events
4
group Id
EG002
num Affected
7
num At Risk
40
num Events
11
group Id
EG003
num Affected
3
num At Risk
29
num Events
3
term
Cytokine Release Syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
0
num At Risk
17
num Events
0
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
1
num At Risk
40
num Events
1
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Drug Hypersensitivity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
2
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Adrenal Insufficiency

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
5
num At Risk
17
num Events
5
group Id
EG001
num Affected
1
num At Risk
20
num Events
1
group Id
EG002
num Affected
7
num At Risk
40
num Events
7
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Covid-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Cystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
1
num At Risk
29
num Events
1
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
2
num At Risk
29
num Events
2
term
Oral Fungal Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Oral Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Pharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
1
num At Risk
20
num Events
1
group Id
EG002
num Affected
1
num At Risk
40
num Events
1
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
1
num At Risk
40
num Events
1
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Urinary Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
0
num At Risk
17
num Events
0
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
2
num At Risk
29
num Events
2
term
Vascular Device Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
1
num At Risk
29
num Events
1
term
Anaemia

Complete source fields

description

Analysis was performed on the exposed population.

event Groups

deaths Num Affected
3
deaths Num At Risk
17
description
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of \>=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
id
EG000
other Num Affected
16
other Num At Risk
17
serious Num Affected
6
serious Num At Risk
17
title
Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
deaths Num Affected
13
deaths Num At Risk
20
description
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
id
EG001
other Num Affected
18
other Num At Risk
20
serious Num Affected
11
serious Num At Risk
20
title
Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
deaths Num Affected
26
deaths Num At Risk
40
description
Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
id
EG002
other Num Affected
38
other Num At Risk
40
serious Num Affected
21
serious Num At Risk
40
title
Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
deaths Num Affected
18
deaths Num At Risk
29
description
Participants with mesothelioma who had no SOC established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
id
EG003
other Num Affected
27
other Num At Risk
29
serious Num Affected
13
serious Num At Risk
29
title
Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
5
num At Risk
17
num Events
5
group Id
EG001
num Affected
1
num At Risk
20
num Events
1
group Id
EG002
num Affected
7
num At Risk
40
num Events
7
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Covid-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Cystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
1
num At Risk
29
num Events
1
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
2
num At Risk
29
num Events
2
term
Oral Fungal Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Oral Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Pharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
1
num At Risk
20
num Events
1
group Id
EG002
num Affected
1
num At Risk
40
num Events
1
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
1
num At Risk
40
num Events
1
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Urinary Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
0
num At Risk
17
num Events
0
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
2
num At Risk
29
num Events
2
term
Vascular Device Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
1
num At Risk
29
num Events
1
term
Anaemia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
0
num At Risk
17
num Events
0
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
1
num At Risk
40
num Events
1
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Covid-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
0
num At Risk
17
num Events
0
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
1
num At Risk
29
num Events
1
term
Oesophageal Candidiasis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
0
num At Risk
17
num Events
0
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
1
num At Risk
29
num Events
1
term
Pleural Infection Bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
0
num At Risk
17
num Events
0
group Id
EG001
num Affected
1
num At Risk
20
num Events
1
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
0
num At Risk
17
num Events
0
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
1
num At Risk
40
num Events
1
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Septic Shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Urosepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
0
num At Risk
17
num Events
0
group Id
EG001
num Affected
1
num At Risk
20
num Events
1
group Id
EG002
num Affected
1
num At Risk
40
num Events
1
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
0
num At Risk
17
num Events
0
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
1
num At Risk
29
num Events
1
term
Immune Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
0
num At Risk
17
num Events
0
group Id
EG001
num Affected
3
num At Risk
20
num Events
4
group Id
EG002
num Affected
7
num At Risk
40
num Events
11
group Id
EG003
num Affected
3
num At Risk
29
num Events
3
term
Cytokine Release Syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
0
num At Risk
17
num Events
0
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
1
num At Risk
40
num Events
1
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Drug Hypersensitivity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDra 27.0
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
2
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
40
num Events
0
group Id
EG003
num Affected
0
num At Risk
29
num Events
0
term
Adrenal Insufficiency

time Frame

Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 months.

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Preserved source evidence · Not medical advice