NCT03860844 · ADVERSE EVENTS

Adverse events

Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia · Source last updated 2025-09-09

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: TEAEs were collected from the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort). All-cause mortality (Deaths) was collected for the entire study duration, a maximum of 45 months
Other-event reporting threshold: 5%

Analysis was performed on the AT population.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
B-cell Acute Lymphoblastic Leukemia (B-ALL) Participants with B-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.	19 / 27	26 / 27	17 / 27
T-cell Acute Lymphoblastic Leukemia (T-ALL) Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.	12 / 13	12 / 13	8 / 13
Acute Myeloid Leukemia (AML) Participants with AML received isatuximab 20 mg/kg IV infusion on Days 1, 8, and 15 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.	17 / 27	24 / 27	18 / 27
All Participants All participants in the study were included in this cohort.	48 / 67	62 / 67	43 / 67

Group identifiers: EG000: B-cell Acute Lymphoblastic Leukemia (B-ALL) · EG001: T-cell Acute Lymphoblastic Leukemia (T-ALL) · EG002: Acute Myeloid Leukemia (AML) · EG003: All Participants

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 26.0
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Bacterial Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Catheter Site Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
1
num At Risk
27
num Events
1
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Device Related Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Disseminated Aspergillosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
1
num At Risk
27
num Events
1
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Encephalitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Escherichia Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Fournier's Gangrene
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
2
num At Risk
67
num Events
2
term
Fungal Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
1
num At Risk
27
num Events
1
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Fungal Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
1
num At Risk
27
num Events
1
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Genital Herpes Zoster

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 26.0
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
2
num At Risk
27
num Events
2
group Id
EG003
num Affected
4
num At Risk
67
num Events
4
term
Conjunctivitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
2
num At Risk
27
num Events
2
group Id
EG003
num Affected
3
num At Risk
67
num Events
3
term
Device Related Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Lip Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Oral Candidiasis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
2
num At Risk
67
num Events
2
term
Oral Herpes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
2
num At Risk
27
num Events
2
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
2
num At Risk
67
num Events
2
term
Respiratory Syncytial Virus Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Skin Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
2
num At Risk
27
num Events
2
group Id
EG003
num Affected
2
num At Risk
67
num Events
2
term
Upper Respiratory Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Viral Rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
2
num At Risk
27
num Events
5
group Id
EG003
num Affected
3
num At Risk
67
num Events
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
4
num At Risk
27
num Events
6
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
5
num At Risk
27
num Events
5
group Id
EG003
num Affected
10
num At Risk
67
num Events
12
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Haemolysis

Complete source fields

description

Analysis was performed on the AT population.

event Groups

deaths Num Affected
17
deaths Num At Risk
27
description
Participants with B-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.
id
EG000
other Num Affected
26
other Num At Risk
27
serious Num Affected
19
serious Num At Risk
27
title
B-cell Acute Lymphoblastic Leukemia (B-ALL)
deaths Num Affected
8
deaths Num At Risk
13
description
Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.
id
EG001
other Num Affected
12
other Num At Risk
13
serious Num Affected
12
serious Num At Risk
13
title
T-cell Acute Lymphoblastic Leukemia (T-ALL)
deaths Num Affected
18
deaths Num At Risk
27
description
Participants with AML received isatuximab 20 mg/kg IV infusion on Days 1, 8, and 15 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.
id
EG002
other Num Affected
24
other Num At Risk
27
serious Num Affected
17
serious Num At Risk
27
title
Acute Myeloid Leukemia (AML)
deaths Num Affected
43
deaths Num At Risk
67
description
All participants in the study were included in this cohort.
id
EG003
other Num Affected
62
other Num At Risk
67
serious Num Affected
48
serious Num At Risk
67
title
All Participants

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
2
num At Risk
27
num Events
2
group Id
EG003
num Affected
4
num At Risk
67
num Events
4
term
Conjunctivitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
2
num At Risk
27
num Events
2
group Id
EG003
num Affected
3
num At Risk
67
num Events
3
term
Device Related Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Lip Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Oral Candidiasis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
2
num At Risk
67
num Events
2
term
Oral Herpes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
2
num At Risk
27
num Events
2
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
2
num At Risk
67
num Events
2
term
Respiratory Syncytial Virus Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Skin Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
2
num At Risk
27
num Events
2
group Id
EG003
num Affected
2
num At Risk
67
num Events
2
term
Upper Respiratory Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Viral Rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
2
num At Risk
27
num Events
5
group Id
EG003
num Affected
3
num At Risk
67
num Events
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
4
num At Risk
27
num Events
6
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
5
num At Risk
27
num Events
5
group Id
EG003
num Affected
10
num At Risk
67
num Events
12
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Haemolysis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Bacterial Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Catheter Site Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
1
num At Risk
27
num Events
1
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Device Related Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Disseminated Aspergillosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
1
num At Risk
27
num Events
1
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Encephalitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Escherichia Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Fournier's Gangrene
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
group Id
EG002
num Affected
0
num At Risk
27
num Events
0
group Id
EG003
num Affected
2
num At Risk
67
num Events
2
term
Fungal Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
1
num At Risk
27
num Events
1
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Fungal Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 26.0
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
group Id
EG002
num Affected
1
num At Risk
27
num Events
1
group Id
EG003
num Affected
1
num At Risk
67
num Events
1
term
Genital Herpes Zoster

time Frame

TEAEs were collected from the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort). All-cause mortality (Deaths) was collected for the entire study duration, a maximum of 45 months

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Preserved source evidence · Not medical advice