NCT03384654 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma · Source last updated 2025-05-25

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: From baseline (Day 1) up to 4 years 4 months
Other-event reporting threshold: 5%

The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 1: B-cell ALL (1-17 Years) Participants with relapsed/refractory B-cell ALL received intrathecal methotrexate (MTX) 8 milligrams (mg): 1 to less than (\<) 2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: greater than or equal to (\>=) 9 years on Cycle 1 Day 1 (for all participants) and Cycle 2 and later Day 1 each Cycle (for CNS negative participants); for CNS positive participants: along with MTX, hydrocortisone (HC)/cytarabine (ARA-C) was administered per local standard practice; daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion weekly on Days 1, 8, 15 and 22 of Cycles 1 and 2 then every 2 weeks on Days 1, 15 of Cycle 3 to 6 and every 4 weeks on Day 1 of Cycle 7 and onward; vincristine 1.5 milligrams per meter square (mg/m\^2) IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1, then every 2 weeks on Days 1 and 15 of Cycle 2 and every 4 weeks on Day 1 of Cycle 3 and onward; prednisone 40 mg/m\^2 orally daily on Day 1 to 28 of Cycle 1 and on Day 1 to 5 of Cycle 2 onward. Participants received treatment until disease progression, unacceptable toxicity, or proceeding hematopoietic stem cell transplant after complete response (CR), whichever came first (maximum duration: 2.3 months).	3 / 7	7 / 7	7 / 7
Cohort 2: T-Cell ALL (1-17 Years) Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV infusion once on Day 1; vincristine 1.5 mg/m\^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m\^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide IV 1 g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months).	16 / 24	24 / 24	14 / 24
Cohort 2: T-Cell ALL (18-30 Years) Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m\^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m\^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg:\>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide 1g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months).	4 / 5	5 / 5	3 / 5
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m\^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m\^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg:\>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide 1g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months).	7 / 10	10 / 10	8 / 10

Group identifiers: EG000: Cohort 1: B-cell ALL (1-17 Years) · EG001: Cohort 2: T-Cell ALL (1-17 Years) · EG002: Cohort 2: T-Cell ALL (18-30 Years) · EG003: Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
3
num At Risk
7
group Id
EG001
num Affected
6
num At Risk
24
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
2
num At Risk
10
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
2
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
24
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Anal Fistula
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
2
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Gastritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Proctalgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
24
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Death
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
General Physical Health Deterioration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Mucosal Inflammation

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
4
num At Risk
7
group Id
EG001
num Affected
16
num At Risk
24
group Id
EG002
num Affected
2
num At Risk
5
group Id
EG003
num Affected
10
num At Risk
10
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
2
num At Risk
7
group Id
EG001
num Affected
7
num At Risk
24
group Id
EG002
num Affected
2
num At Risk
5
group Id
EG003
num Affected
4
num At Risk
10
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
10
term
Hypocoagulable State
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
3
num At Risk
7
group Id
EG001
num Affected
9
num At Risk
24
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
5
num At Risk
10
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
10
term
Lymph Node Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
24
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Lymphocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
5
num At Risk
24
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
10
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
2
num At Risk
7
group Id
EG001
num Affected
15
num At Risk
24
group Id
EG002
num Affected
2
num At Risk
5
group Id
EG003
num Affected
6
num At Risk
10
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
2
num At Risk
7
group Id
EG001
num Affected
18
num At Risk
24
group Id
EG002
num Affected
3
num At Risk
5
group Id
EG003
num Affected
9
num At Risk
10
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
24
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Cardiac Failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
2
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
10
term
Sinus Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
2
num At Risk
7
group Id
EG001
num Affected
3
num At Risk
24
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
10
term
Sinus Tachycardia

Complete source fields

description

The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.

event Groups

deaths Num Affected
7
deaths Num At Risk
7
description
Participants with relapsed/refractory B-cell ALL received intrathecal methotrexate (MTX) 8 milligrams (mg): 1 to less than (\<) 2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: greater than or equal to (\>=) 9 years on Cycle 1 Day 1 (for all participants) and Cycle 2 and later Day 1 each Cycle (for CNS negative participants); for CNS positive participants: along with MTX, hydrocortisone (HC)/cytarabine (ARA-C) was administered per local standard practice; daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion weekly on Days 1, 8, 15 and 22 of Cycles 1 and 2 then every 2 weeks on Days 1, 15 of Cycle 3 to 6 and every 4 weeks on Day 1 of Cycle 7 and onward; vincristine 1.5 milligrams per meter square (mg/m\^2) IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1, then every 2 weeks on Days 1 and 15 of Cycle 2 and every 4 weeks on Day 1 of Cycle 3 and onward; prednisone 40 mg/m\^2 orally daily on Day 1 to 28 of Cycle 1 and on Day 1 to 5 of Cycle 2 onward. Participants received treatment until disease progression, unacceptable toxicity, or proceeding hematopoietic stem cell transplant after complete response (CR), whichever came first (maximum duration: 2.3 months).
id
EG000
other Num Affected
7
other Num At Risk
7
serious Num Affected
3
serious Num At Risk
7
title
Cohort 1: B-cell ALL (1-17 Years)
deaths Num Affected
14
deaths Num At Risk
24
description
Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV infusion once on Day 1; vincristine 1.5 mg/m\^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m\^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide IV 1 g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months).
id
EG001
other Num Affected
24
other Num At Risk
24
serious Num Affected
16
serious Num At Risk
24
title
Cohort 2: T-Cell ALL (1-17 Years)
deaths Num Affected
3
deaths Num At Risk
5
description
Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m\^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m\^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg:\>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide 1g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months).
id
EG002
other Num Affected
5
other Num At Risk
5
serious Num Affected
4
serious Num At Risk
5
title
Cohort 2: T-Cell ALL (18-30 Years)
deaths Num Affected
8
deaths Num At Risk
10
description
Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m\^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m\^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg:\>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide 1g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months).
id
EG003
other Num Affected
10
other Num At Risk
10
serious Num Affected
7
serious Num At Risk
10
title
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
4
num At Risk
7
group Id
EG001
num Affected
16
num At Risk
24
group Id
EG002
num Affected
2
num At Risk
5
group Id
EG003
num Affected
10
num At Risk
10
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
2
num At Risk
7
group Id
EG001
num Affected
7
num At Risk
24
group Id
EG002
num Affected
2
num At Risk
5
group Id
EG003
num Affected
4
num At Risk
10
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
10
term
Hypocoagulable State
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
3
num At Risk
7
group Id
EG001
num Affected
9
num At Risk
24
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
5
num At Risk
10
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
10
term
Lymph Node Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
24
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Lymphocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
5
num At Risk
24
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
10
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
2
num At Risk
7
group Id
EG001
num Affected
15
num At Risk
24
group Id
EG002
num Affected
2
num At Risk
5
group Id
EG003
num Affected
6
num At Risk
10
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
2
num At Risk
7
group Id
EG001
num Affected
18
num At Risk
24
group Id
EG002
num Affected
3
num At Risk
5
group Id
EG003
num Affected
9
num At Risk
10
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
24
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Cardiac Failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
2
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
10
term
Sinus Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
2
num At Risk
7
group Id
EG001
num Affected
3
num At Risk
24
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
10
term
Sinus Tachycardia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
3
num At Risk
7
group Id
EG001
num Affected
6
num At Risk
24
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
2
num At Risk
10
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
2
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
24
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Anal Fistula
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
2
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Gastritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Proctalgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
24
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Death
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
General Physical Health Deterioration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
24
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
term
Mucosal Inflammation

time Frame

From baseline (Day 1) up to 4 years 4 months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice