NCT01332968 · ADVERSE EVENTS

Adverse events

A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM) · Source last updated 2022-08-11

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 10 years
Other-event reporting threshold: 5%

The safety analysis population included all participants who received any amount of any study drug and participants were analyzed according to the treatment received.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Rituximab+Chemotherapy Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	309 / 692	675 / 692	111 / 692
Obinutuzumab+Chemotherapy Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	361 / 698	690 / 698	104 / 698

Group identifiers: EG000: Rituximab+Chemotherapy · EG001: Obinutuzumab+Chemotherapy

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 24.0
stats
group Id
EG000
num Affected
1
num At Risk
692
num Events
1
group Id
EG001
num Affected
6
num At Risk
698
num Events
7
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
692
num Events
1
group Id
EG001
num Affected
0
num At Risk
698
num Events
0
term
AUTOIMMUNE HAEMOLYTIC ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
692
num Events
0
group Id
EG001
num Affected
1
num At Risk
698
num Events
1
term
DISSEMINATED INTRAVASCULAR COAGULATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
23
num At Risk
692
num Events
31
group Id
EG001
num Affected
36
num At Risk
698
num Events
48
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
692
num Events
0
group Id
EG001
num Affected
1
num At Risk
698
num Events
1
term
GRANULOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
692
num Events
1
group Id
EG001
num Affected
0
num At Risk
698
num Events
0
term
HAEMOLYSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
692
num Events
1
group Id
EG001
num Affected
0
num At Risk
698
num Events
0
term
HAEMOLYTIC ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
692
num Events
0
group Id
EG001
num Affected
1
num At Risk
698
num Events
1
term
IMMUNE THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
6
num At Risk
692
num Events
10
group Id
EG001
num Affected
4
num At Risk
698
num Events
4
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
692
num Events
0
group Id
EG001
num Affected
3
num At Risk
698
num Events
4
term
MYELOSUPPRESSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
33
num At Risk
692
num Events
46
group Id
EG001
num Affected
28
num At Risk
698
num Events
31
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
692
num Events
1
group Id
EG001
num Affected
2
num At Risk
698
num Events
2
term
SPLENOMEGALY

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 24.0
stats
group Id
EG000
num Affected
72
num At Risk
692
num Events
95
group Id
EG001
num Affected
75
num At Risk
698
num Events
88
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
91
num At Risk
692
num Events
267
group Id
EG001
num Affected
87
num At Risk
698
num Events
222
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
307
num At Risk
692
num Events
777
group Id
EG001
num Affected
348
num At Risk
698
num Events
885
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
52
num At Risk
692
num Events
79
group Id
EG001
num Affected
90
num At Risk
698
num Events
150
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
78
num At Risk
692
num Events
95
group Id
EG001
num Affected
69
num At Risk
698
num Events
84
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
53
num At Risk
692
num Events
60
group Id
EG001
num Affected
57
num At Risk
698
num Events
64
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
221
num At Risk
692
num Events
301
group Id
EG001
num Affected
249
num At Risk
698
num Events
326
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
168
num At Risk
692
num Events
253
group Id
EG001
num Affected
207
num At Risk
698
num Events
318
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
23
num At Risk
692
num Events
25
group Id
EG001
num Affected
36
num At Risk
698
num Events
40
term
DRY MOUTH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
50
num At Risk
692
num Events
56
group Id
EG001
num Affected
65
num At Risk
698
num Events
82
term
DYSPEPSIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
338
num At Risk
692
num Events
577
group Id
EG001
num Affected
354
num At Risk
698
num Events
594
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
55
num At Risk
692
num Events
71
group Id
EG001
num Affected
54
num At Risk
698
num Events
72
term
STOMATITIS

Complete source fields

description

The safety analysis population included all participants who received any amount of any study drug and participants were analyzed according to the treatment received.

event Groups

deaths Num Affected
111
deaths Num At Risk
692
description
Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
id
EG000
other Num Affected
675
other Num At Risk
692
serious Num Affected
309
serious Num At Risk
692
title
Rituximab+Chemotherapy
deaths Num Affected
104
deaths Num At Risk
698
description
Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
id
EG001
other Num Affected
690
other Num At Risk
698
serious Num Affected
361
serious Num At Risk
698
title
Obinutuzumab+Chemotherapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
72
num At Risk
692
num Events
95
group Id
EG001
num Affected
75
num At Risk
698
num Events
88
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
91
num At Risk
692
num Events
267
group Id
EG001
num Affected
87
num At Risk
698
num Events
222
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
307
num At Risk
692
num Events
777
group Id
EG001
num Affected
348
num At Risk
698
num Events
885
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
52
num At Risk
692
num Events
79
group Id
EG001
num Affected
90
num At Risk
698
num Events
150
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
78
num At Risk
692
num Events
95
group Id
EG001
num Affected
69
num At Risk
698
num Events
84
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
53
num At Risk
692
num Events
60
group Id
EG001
num Affected
57
num At Risk
698
num Events
64
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
221
num At Risk
692
num Events
301
group Id
EG001
num Affected
249
num At Risk
698
num Events
326
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
168
num At Risk
692
num Events
253
group Id
EG001
num Affected
207
num At Risk
698
num Events
318
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
23
num At Risk
692
num Events
25
group Id
EG001
num Affected
36
num At Risk
698
num Events
40
term
DRY MOUTH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
50
num At Risk
692
num Events
56
group Id
EG001
num Affected
65
num At Risk
698
num Events
82
term
DYSPEPSIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
338
num At Risk
692
num Events
577
group Id
EG001
num Affected
354
num At Risk
698
num Events
594
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
55
num At Risk
692
num Events
71
group Id
EG001
num Affected
54
num At Risk
698
num Events
72
term
STOMATITIS

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
692
num Events
1
group Id
EG001
num Affected
6
num At Risk
698
num Events
7
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
692
num Events
1
group Id
EG001
num Affected
0
num At Risk
698
num Events
0
term
AUTOIMMUNE HAEMOLYTIC ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
692
num Events
0
group Id
EG001
num Affected
1
num At Risk
698
num Events
1
term
DISSEMINATED INTRAVASCULAR COAGULATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
23
num At Risk
692
num Events
31
group Id
EG001
num Affected
36
num At Risk
698
num Events
48
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
692
num Events
0
group Id
EG001
num Affected
1
num At Risk
698
num Events
1
term
GRANULOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
692
num Events
1
group Id
EG001
num Affected
0
num At Risk
698
num Events
0
term
HAEMOLYSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
692
num Events
1
group Id
EG001
num Affected
0
num At Risk
698
num Events
0
term
HAEMOLYTIC ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
692
num Events
0
group Id
EG001
num Affected
1
num At Risk
698
num Events
1
term
IMMUNE THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
6
num At Risk
692
num Events
10
group Id
EG001
num Affected
4
num At Risk
698
num Events
4
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
692
num Events
0
group Id
EG001
num Affected
3
num At Risk
698
num Events
4
term
MYELOSUPPRESSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
33
num At Risk
692
num Events
46
group Id
EG001
num Affected
28
num At Risk
698
num Events
31
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
692
num Events
1
group Id
EG001
num Affected
2
num At Risk
698
num Events
2
term
SPLENOMEGALY

time Frame

Baseline up to 10 years

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

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