NCT01059630 · ADVERSE EVENTS

Adverse events

A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN) · Source last updated 2020-01-13

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: Baseline up to 8.5 years
Other-event reporting threshold: 5%

Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Bendamustine Alone Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	76 / 203	194 / 203	Not reported / Not reported
Obinutuzumab + Bendamustine Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).	91 / 204	200 / 204	Not reported / Not reported

Group identifiers: EG000: Bendamustine Alone · EG001: Obinutuzumab + 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 v21.1
stats
group Id
EG000
num Affected
0
num At Risk
203
num Events
0
group Id
EG001
num Affected
1
num At Risk
204
num Events
1
term
AGRANULOCYTOSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
3
num At Risk
203
num Events
3
group Id
EG001
num Affected
3
num At Risk
204
num Events
3
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
6
num At Risk
203
num Events
6
group Id
EG001
num Affected
11
num At Risk
204
num Events
17
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
204
num Events
0
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
6
num At Risk
204
num Events
6
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
0
num At Risk
203
num Events
0
group Id
EG001
num Affected
5
num At Risk
204
num Events
5
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
2
group Id
EG001
num Affected
2
num At Risk
204
num Events
2
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
0
num At Risk
203
num Events
0
group Id
EG001
num Affected
1
num At Risk
204
num Events
1
term
ATRIAL FLUTTER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
0
num At Risk
203
num Events
0
group Id
EG001
num Affected
2
num At Risk
204
num Events
3
term
CARDIAC FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
0
num At Risk
203
num Events
0
group Id
EG001
num Affected
1
num At Risk
204
num Events
1
term
CORONARY ARTERY DISEASE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
1
num At Risk
204
num Events
2
term
MYOCARDIAL INFARCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
204
num Events
0
term
PAROXYSMAL ARRHYTHMIA

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 v21.1
stats
group Id
EG000
num Affected
34
num At Risk
203
num Events
41
group Id
EG001
num Affected
23
num At Risk
204
num Events
36
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
59
num At Risk
203
num Events
103
group Id
EG001
num Affected
74
num At Risk
204
num Events
150
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
50
num At Risk
203
num Events
101
group Id
EG001
num Affected
26
num At Risk
204
num Events
54
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
11
num At Risk
203
num Events
12
group Id
EG001
num Affected
6
num At Risk
204
num Events
6
term
ABDOMINAL DISTENSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
20
num At Risk
203
num Events
23
group Id
EG001
num Affected
16
num At Risk
204
num Events
18
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
15
num At Risk
203
num Events
19
group Id
EG001
num Affected
11
num At Risk
204
num Events
12
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
40
num At Risk
203
num Events
55
group Id
EG001
num Affected
42
num At Risk
204
num Events
56
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
61
num At Risk
203
num Events
83
group Id
EG001
num Affected
57
num At Risk
204
num Events
81
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
12
num At Risk
203
num Events
15
group Id
EG001
num Affected
8
num At Risk
204
num Events
8
term
DRY MOUTH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
9
num At Risk
203
num Events
11
group Id
EG001
num Affected
13
num At Risk
204
num Events
16
term
DYSPEPSIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
123
num At Risk
203
num Events
227
group Id
EG001
num Affected
107
num At Risk
204
num Events
210
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
54
num At Risk
203
num Events
87
group Id
EG001
num Affected
44
num At Risk
204
num Events
67
term
VOMITING

Complete source fields

description

Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.

event Groups

description
Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
id
EG000
other Num Affected
194
other Num At Risk
203
serious Num Affected
76
serious Num At Risk
203
title
Bendamustine Alone
description
Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
id
EG001
other Num Affected
200
other Num At Risk
204
serious Num Affected
91
serious Num At Risk
204
title
Obinutuzumab + Bendamustine

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
34
num At Risk
203
num Events
41
group Id
EG001
num Affected
23
num At Risk
204
num Events
36
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
59
num At Risk
203
num Events
103
group Id
EG001
num Affected
74
num At Risk
204
num Events
150
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
50
num At Risk
203
num Events
101
group Id
EG001
num Affected
26
num At Risk
204
num Events
54
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
11
num At Risk
203
num Events
12
group Id
EG001
num Affected
6
num At Risk
204
num Events
6
term
ABDOMINAL DISTENSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
20
num At Risk
203
num Events
23
group Id
EG001
num Affected
16
num At Risk
204
num Events
18
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
15
num At Risk
203
num Events
19
group Id
EG001
num Affected
11
num At Risk
204
num Events
12
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
40
num At Risk
203
num Events
55
group Id
EG001
num Affected
42
num At Risk
204
num Events
56
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
61
num At Risk
203
num Events
83
group Id
EG001
num Affected
57
num At Risk
204
num Events
81
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
12
num At Risk
203
num Events
15
group Id
EG001
num Affected
8
num At Risk
204
num Events
8
term
DRY MOUTH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
9
num At Risk
203
num Events
11
group Id
EG001
num Affected
13
num At Risk
204
num Events
16
term
DYSPEPSIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
123
num At Risk
203
num Events
227
group Id
EG001
num Affected
107
num At Risk
204
num Events
210
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
54
num At Risk
203
num Events
87
group Id
EG001
num Affected
44
num At Risk
204
num Events
67
term
VOMITING

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
0
num At Risk
203
num Events
0
group Id
EG001
num Affected
1
num At Risk
204
num Events
1
term
AGRANULOCYTOSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
3
num At Risk
203
num Events
3
group Id
EG001
num Affected
3
num At Risk
204
num Events
3
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
6
num At Risk
203
num Events
6
group Id
EG001
num Affected
11
num At Risk
204
num Events
17
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
204
num Events
0
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
6
num At Risk
204
num Events
6
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
0
num At Risk
203
num Events
0
group Id
EG001
num Affected
5
num At Risk
204
num Events
5
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
2
group Id
EG001
num Affected
2
num At Risk
204
num Events
2
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
0
num At Risk
203
num Events
0
group Id
EG001
num Affected
1
num At Risk
204
num Events
1
term
ATRIAL FLUTTER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
0
num At Risk
203
num Events
0
group Id
EG001
num Affected
2
num At Risk
204
num Events
3
term
CARDIAC FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
0
num At Risk
203
num Events
0
group Id
EG001
num Affected
1
num At Risk
204
num Events
1
term
CORONARY ARTERY DISEASE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
1
num At Risk
204
num Events
2
term
MYOCARDIAL INFARCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v21.1
stats
group Id
EG000
num Affected
1
num At Risk
203
num Events
1
group Id
EG001
num Affected
0
num At Risk
204
num Events
0
term
PAROXYSMAL ARRHYTHMIA

time Frame

Baseline up to 8.5 years

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

Preserved source evidence · Independent clinical review pending · Not medical advice