NCT01088984 · ADVERSE EVENTS

Adverse events

Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia · Source last updated 2016-05-23

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: Screening (Day -14 to Day-1) through end of treatment (up to 12 35-day cycles), plus 30 days.
Other-event reporting threshold: 5%

Participants were given both dosages for varying lengths and the adverse events were not reported according to which timepoint neither at which dosage events occurred.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Bendamustine Bendamustine 90 or 120 mg/m\^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.	33 / 43	43 / 43	Not reported / Not reported

Group identifiers: EG000: Bendamustine

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 13.0
stats
group Id
EG000
num Affected
12
num At Risk
43
num Events
13
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
2
num At Risk
43
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
2
num At Risk
43
num Events
2
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
2
num At Risk
43
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Cardiopulmonary failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Proctitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
2
term
Multi-organ failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
4
num At Risk
43
num Events
7
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Portal vein thrombosis

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 13.0
stats
group Id
EG000
num Affected
28
num At Risk
43
num Events
92
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
15
num At Risk
43
num Events
19
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
3
num At Risk
43
num Events
10
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
5
num At Risk
43
num Events
8
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
4
num At Risk
43
num Events
5
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
14
num At Risk
43
num Events
74
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
9
num At Risk
43
num Events
13
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
7
num At Risk
43
num Events
8
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
14
num At Risk
43
num Events
28
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
3
num At Risk
43
num Events
3
term
Gingival bleeding
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
20
num At Risk
43
num Events
26
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
15
num At Risk
43
num Events
31
term
Vomiting

Complete source fields

description

Participants were given both dosages for varying lengths and the adverse events were not reported according to which timepoint neither at which dosage events occurred.

event Groups

description
Bendamustine 90 or 120 mg/m\^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
id
EG000
other Num Affected
43
other Num At Risk
43
serious Num Affected
33
serious Num At Risk
43
title
Bendamustine

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
28
num At Risk
43
num Events
92
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
15
num At Risk
43
num Events
19
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
3
num At Risk
43
num Events
10
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
5
num At Risk
43
num Events
8
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
4
num At Risk
43
num Events
5
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
14
num At Risk
43
num Events
74
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
9
num At Risk
43
num Events
13
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
7
num At Risk
43
num Events
8
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
14
num At Risk
43
num Events
28
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
3
num At Risk
43
num Events
3
term
Gingival bleeding
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
20
num At Risk
43
num Events
26
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
15
num At Risk
43
num Events
31
term
Vomiting

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
12
num At Risk
43
num Events
13
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
2
num At Risk
43
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
2
num At Risk
43
num Events
2
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
2
num At Risk
43
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Cardiopulmonary failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Proctitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
2
term
Multi-organ failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
4
num At Risk
43
num Events
7
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 13.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Portal vein thrombosis

time Frame

Screening (Day -14 to Day-1) through end of treatment (up to 12 35-day cycles), plus 30 days.

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