NCT03817853 · ADVERSE EVENTS

Adverse events

An Open-Label, Single Arm Study of Obinutuzumab Short Duration Infusion in Patients With Previously Untreated Advanced Follicular Lymphoma · Source last updated 2024-04-04

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 end of study (approximately 4 years)
Other-event reporting threshold: 0.05%

An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product, regardless of causal attribution. Grading was completed according to the CTCAE, version 5.0.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
All Participants Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.	21 / 113	111 / 113	9 / 113
Maintenance Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression).	17 / 95	76 / 95	8 / 95
Follow-up Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.	11 / 99	13 / 99	4 / 99

Group identifiers: EG000: All Participants · EG001: Maintenance · EG002: Follow-up

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 version 25.1
stats
group Id
EG000
num Affected
5
num At Risk
113
num Events
5
group Id
EG001
num Affected
1
num At Risk
95
num Events
1
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
2
num At Risk
113
num Events
2
group Id
EG001
num Affected
1
num At Risk
95
num Events
1
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
num Events
2
group Id
EG001
num Affected
0
num At Risk
95
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
0
num At Risk
113
num Events
0
group Id
EG001
num Affected
0
num At Risk
95
num Events
0
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
num Events
1
group Id
EG001
num Affected
0
num At Risk
95
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
0
num At Risk
113
num Events
0
group Id
EG001
num Affected
0
num At Risk
95
num Events
0
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
num Events
1
group Id
EG001
num Affected
0
num At Risk
95
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Cardiorenal syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
num Events
1
group Id
EG001
num Affected
0
num At Risk
95
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Lower gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
num Events
1
group Id
EG001
num Affected
0
num At Risk
95
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
num Events
1
group Id
EG001
num Affected
0
num At Risk
95
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
num Events
1
group Id
EG001
num Affected
0
num At Risk
95
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
num Events
1
group Id
EG001
num Affected
1
num At Risk
95
num Events
1
group Id
EG002
num Affected
4
num At Risk
99
num Events
4
term
COVID-19

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 version 25.1
stats
group Id
EG000
num Affected
20
num At Risk
113
num Events
25
group Id
EG001
num Affected
3
num At Risk
95
num Events
3
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
20
num At Risk
113
num Events
34
group Id
EG001
num Affected
3
num At Risk
95
num Events
6
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
22
num At Risk
113
num Events
36
group Id
EG001
num Affected
4
num At Risk
95
num Events
5
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
68
num At Risk
113
num Events
116
group Id
EG001
num Affected
16
num At Risk
95
num Events
27
group Id
EG002
num Affected
2
num At Risk
99
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
20
num At Risk
113
num Events
28
group Id
EG001
num Affected
4
num At Risk
95
num Events
8
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
11
num At Risk
113
num Events
13
group Id
EG001
num Affected
3
num At Risk
95
num Events
3
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
9
num At Risk
113
num Events
10
group Id
EG001
num Affected
4
num At Risk
95
num Events
4
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
39
num At Risk
113
num Events
42
group Id
EG001
num Affected
6
num At Risk
95
num Events
6
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
15
num At Risk
113
num Events
18
group Id
EG001
num Affected
5
num At Risk
95
num Events
6
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
8
num At Risk
113
num Events
8
group Id
EG001
num Affected
3
num At Risk
95
num Events
4
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
48
num At Risk
113
num Events
67
group Id
EG001
num Affected
4
num At Risk
95
num Events
6
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
15
num At Risk
113
num Events
17
group Id
EG001
num Affected
1
num At Risk
95
num Events
1
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Vomiting

Complete source fields

description

event Groups

deaths Num Affected
9
deaths Num At Risk
113
description
Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.
id
EG000
other Num Affected
111
other Num At Risk
113
serious Num Affected
21
serious Num At Risk
113
title
All Participants
deaths Num Affected
8
deaths Num At Risk
95
description
Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression).
id
EG001
other Num Affected
76
other Num At Risk
95
serious Num Affected
17
serious Num At Risk
95
title
Maintenance
deaths Num Affected
4
deaths Num At Risk
99
description
Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.
id
EG002
other Num Affected
13
other Num At Risk
99
serious Num Affected
11
serious Num At Risk
99
title
Follow-up

frequency Threshold

0.05

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
20
num At Risk
113
num Events
25
group Id
EG001
num Affected
3
num At Risk
95
num Events
3
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
20
num At Risk
113
num Events
34
group Id
EG001
num Affected
3
num At Risk
95
num Events
6
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
22
num At Risk
113
num Events
36
group Id
EG001
num Affected
4
num At Risk
95
num Events
5
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
68
num At Risk
113
num Events
116
group Id
EG001
num Affected
16
num At Risk
95
num Events
27
group Id
EG002
num Affected
2
num At Risk
99
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
20
num At Risk
113
num Events
28
group Id
EG001
num Affected
4
num At Risk
95
num Events
8
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
11
num At Risk
113
num Events
13
group Id
EG001
num Affected
3
num At Risk
95
num Events
3
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
9
num At Risk
113
num Events
10
group Id
EG001
num Affected
4
num At Risk
95
num Events
4
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
39
num At Risk
113
num Events
42
group Id
EG001
num Affected
6
num At Risk
95
num Events
6
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
15
num At Risk
113
num Events
18
group Id
EG001
num Affected
5
num At Risk
95
num Events
6
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
8
num At Risk
113
num Events
8
group Id
EG001
num Affected
3
num At Risk
95
num Events
4
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
48
num At Risk
113
num Events
67
group Id
EG001
num Affected
4
num At Risk
95
num Events
6
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
15
num At Risk
113
num Events
17
group Id
EG001
num Affected
1
num At Risk
95
num Events
1
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Vomiting

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
5
num At Risk
113
num Events
5
group Id
EG001
num Affected
1
num At Risk
95
num Events
1
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
2
num At Risk
113
num Events
2
group Id
EG001
num Affected
1
num At Risk
95
num Events
1
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
num Events
2
group Id
EG001
num Affected
0
num At Risk
95
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
0
num At Risk
113
num Events
0
group Id
EG001
num Affected
0
num At Risk
95
num Events
0
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
num Events
1
group Id
EG001
num Affected
0
num At Risk
95
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
0
num At Risk
113
num Events
0
group Id
EG001
num Affected
0
num At Risk
95
num Events
0
group Id
EG002
num Affected
1
num At Risk
99
num Events
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
num Events
1
group Id
EG001
num Affected
0
num At Risk
95
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Cardiorenal syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
num Events
1
group Id
EG001
num Affected
0
num At Risk
95
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Lower gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
num Events
1
group Id
EG001
num Affected
0
num At Risk
95
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
num Events
1
group Id
EG001
num Affected
0
num At Risk
95
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
num Events
1
group Id
EG001
num Affected
0
num At Risk
95
num Events
0
group Id
EG002
num Affected
0
num At Risk
99
num Events
0
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 25.1
stats
group Id
EG000
num Affected
1
num At Risk
113
num Events
1
group Id
EG001
num Affected
1
num At Risk
95
num Events
1
group Id
EG002
num Affected
4
num At Risk
99
num Events
4
term
COVID-19

time Frame

Baseline up to end of study (approximately 4 years)

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

Preserved source evidence · Not medical advice