NCT01471782 · ADVERSE EVENTS

Adverse events

Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia · Source last updated 2017-02-08

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 the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle, median treatment duration was 28 days.
Other-event reporting threshold: 5%

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1: Blinatumomab 5 µg/m²/Day Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.	4 / 5	5 / 5	Not reported / Not reported
Phase 1: Blinatumomab 15 µg/m²/Day Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.	4 / 7	7 / 7	Not reported / Not reported
Phase 1+2: Blinatumomab 5/15 µg/m²/Day Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.	39 / 70	70 / 70	Not reported / Not reported
Phase 1: Blinatumomab 15/30 µg/m²/Day Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.	4 / 6	6 / 6	Not reported / Not reported
Phase 1: Blinatumomab 30 µg/m²/Day Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.	3 / 5	5 / 5	Not reported / Not reported
Total All Participants who received blinatumomab administered as a continuous intravenous infusion at a constant daily flow rate.	54 / 93	93 / 93	Not reported / Not reported

Group identifiers: EG000: Phase 1: Blinatumomab 5 µg/m²/Day · EG001: Phase 1: Blinatumomab 15 µg/m²/Day · EG002: Phase 1+2: Blinatumomab 5/15 µg/m²/Day · EG003: Phase 1: Blinatumomab 15/30 µg/m²/Day · EG004: Phase 1: Blinatumomab 30 µg/m²/Day · EG005: Total

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
70
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
8
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
8
num At Risk
93
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
2
num At Risk
93
term
Histiocytosis haematophagic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
70
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
2
num At Risk
93
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Mouth haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Oesophageal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Device malfunction

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
3
num At Risk
5
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
29
num At Risk
70
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
4
num At Risk
5
group Id
EG005
num Affected
40
num At Risk
93
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
70
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Coagulopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
70
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
8
num At Risk
93
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
8
num At Risk
70
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
9
num At Risk
93
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
2
num At Risk
93
term
Hypoglobulinaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
9
num At Risk
70
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
2
num At Risk
5
group Id
EG005
num Affected
14
num At Risk
93
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
2
num At Risk
93
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
12
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
13
num At Risk
93
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
2
num At Risk
5
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
14
num At Risk
70
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
2
num At Risk
5
group Id
EG005
num Affected
21
num At Risk
93
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
70
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
2
num At Risk
5
group Id
EG005
num Affected
6
num At Risk
93
term
Sinus bradycardia

Complete source fields

description

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

event Groups

description
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
id
EG000
other Num Affected
5
other Num At Risk
5
serious Num Affected
4
serious Num At Risk
5
title
Phase 1: Blinatumomab 5 µg/m²/Day
description
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
id
EG001
other Num Affected
7
other Num At Risk
7
serious Num Affected
4
serious Num At Risk
7
title
Phase 1: Blinatumomab 15 µg/m²/Day
description
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
id
EG002
other Num Affected
70
other Num At Risk
70
serious Num Affected
39
serious Num At Risk
70
title
Phase 1+2: Blinatumomab 5/15 µg/m²/Day
description
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
id
EG003
other Num Affected
6
other Num At Risk
6
serious Num Affected
4
serious Num At Risk
6
title
Phase 1: Blinatumomab 15/30 µg/m²/Day
description
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
id
EG004
other Num Affected
5
other Num At Risk
5
serious Num Affected
3
serious Num At Risk
5
title
Phase 1: Blinatumomab 30 µg/m²/Day
description
All Participants who received blinatumomab administered as a continuous intravenous infusion at a constant daily flow rate.
id
EG005
other Num Affected
93
other Num At Risk
93
serious Num Affected
54
serious Num At Risk
93
title
Total

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
3
num At Risk
5
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
29
num At Risk
70
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
4
num At Risk
5
group Id
EG005
num Affected
40
num At Risk
93
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
70
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Coagulopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
70
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
8
num At Risk
93
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
8
num At Risk
70
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
9
num At Risk
93
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
2
num At Risk
93
term
Hypoglobulinaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
9
num At Risk
70
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
2
num At Risk
5
group Id
EG005
num Affected
14
num At Risk
93
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
2
num At Risk
93
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
12
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
13
num At Risk
93
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
2
num At Risk
5
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
14
num At Risk
70
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
2
num At Risk
5
group Id
EG005
num Affected
21
num At Risk
93
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
70
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
2
num At Risk
5
group Id
EG005
num Affected
6
num At Risk
93
term
Sinus bradycardia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
70
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
8
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
8
num At Risk
93
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
2
num At Risk
93
term
Histiocytosis haematophagic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
70
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
2
num At Risk
93
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Mouth haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Oesophageal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 17.1
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
70
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
93
term
Device malfunction

time Frame

From the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle, median treatment duration was 28 days.

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

Preserved source evidence · Not medical advice