NCT01732926 · ADVERSE EVENTS

Adverse events

Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas · Source last updated 2018-11-16

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: Up to 34 months plus 30 days
Other-event reporting threshold: 5%

Safety Analysis Set: all participants who took at least 1 dose of study drug

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Idelalisib + Bendamustine + Rituximab Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) + rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)	229 / 317	315 / 317	Not reported / Not reported
Placebo + Bendamustine + Rituximab Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) + rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)	58 / 155	147 / 155	Not reported / Not reported

Group identifiers: EG000: Idelalisib + Bendamustine + Rituximab · EG001: Placebo + Bendamustine + Rituximab

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 19.0
stats
group Id
EG000
num Affected
8
num At Risk
317
group Id
EG001
num Affected
4
num At Risk
155
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
317
group Id
EG001
num Affected
0
num At Risk
155
term
Aplasia pure red cell
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
317
group Id
EG001
num Affected
0
num At Risk
155
term
Autoimmune haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
317
group Id
EG001
num Affected
0
num At Risk
155
term
Febrile bone marrow aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
45
num At Risk
317
group Id
EG001
num Affected
7
num At Risk
155
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
317
group Id
EG001
num Affected
1
num At Risk
155
term
Haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
317
group Id
EG001
num Affected
0
num At Risk
155
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
317
group Id
EG001
num Affected
0
num At Risk
155
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
8
num At Risk
317
group Id
EG001
num Affected
3
num At Risk
155
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
317
group Id
EG001
num Affected
0
num At Risk
155
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
4
num At Risk
317
group Id
EG001
num Affected
2
num At Risk
155
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
317
group Id
EG001
num Affected
0
num At Risk
155
term
Acute myocardial infarction

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 19.0
stats
group Id
EG000
num Affected
51
num At Risk
317
group Id
EG001
num Affected
18
num At Risk
155
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
18
num At Risk
317
group Id
EG001
num Affected
7
num At Risk
155
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
122
num At Risk
317
group Id
EG001
num Affected
54
num At Risk
155
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
37
num At Risk
317
group Id
EG001
num Affected
18
num At Risk
155
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
39
num At Risk
317
group Id
EG001
num Affected
11
num At Risk
155
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
21
num At Risk
317
group Id
EG001
num Affected
10
num At Risk
155
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
74
num At Risk
317
group Id
EG001
num Affected
31
num At Risk
155
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
158
num At Risk
317
group Id
EG001
num Affected
33
num At Risk
155
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
20
num At Risk
317
group Id
EG001
num Affected
3
num At Risk
155
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
28
num At Risk
317
group Id
EG001
num Affected
9
num At Risk
155
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
17
num At Risk
317
group Id
EG001
num Affected
6
num At Risk
155
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
20
num At Risk
317
group Id
EG001
num Affected
4
num At Risk
155
term
Mouth ulceration

Complete source fields

description

Safety Analysis Set: all participants who took at least 1 dose of study drug

event Groups

description
Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) + rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)
id
EG000
other Num Affected
315
other Num At Risk
317
serious Num Affected
229
serious Num At Risk
317
title
Idelalisib + Bendamustine + Rituximab
description
Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) + rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)
id
EG001
other Num Affected
147
other Num At Risk
155
serious Num Affected
58
serious Num At Risk
155
title
Placebo + Bendamustine + Rituximab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
51
num At Risk
317
group Id
EG001
num Affected
18
num At Risk
155
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
18
num At Risk
317
group Id
EG001
num Affected
7
num At Risk
155
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
122
num At Risk
317
group Id
EG001
num Affected
54
num At Risk
155
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
37
num At Risk
317
group Id
EG001
num Affected
18
num At Risk
155
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
39
num At Risk
317
group Id
EG001
num Affected
11
num At Risk
155
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
21
num At Risk
317
group Id
EG001
num Affected
10
num At Risk
155
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
74
num At Risk
317
group Id
EG001
num Affected
31
num At Risk
155
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
158
num At Risk
317
group Id
EG001
num Affected
33
num At Risk
155
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
20
num At Risk
317
group Id
EG001
num Affected
3
num At Risk
155
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
28
num At Risk
317
group Id
EG001
num Affected
9
num At Risk
155
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
17
num At Risk
317
group Id
EG001
num Affected
6
num At Risk
155
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
20
num At Risk
317
group Id
EG001
num Affected
4
num At Risk
155
term
Mouth ulceration

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
8
num At Risk
317
group Id
EG001
num Affected
4
num At Risk
155
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
317
group Id
EG001
num Affected
0
num At Risk
155
term
Aplasia pure red cell
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
317
group Id
EG001
num Affected
0
num At Risk
155
term
Autoimmune haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
317
group Id
EG001
num Affected
0
num At Risk
155
term
Febrile bone marrow aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
45
num At Risk
317
group Id
EG001
num Affected
7
num At Risk
155
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
317
group Id
EG001
num Affected
1
num At Risk
155
term
Haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
317
group Id
EG001
num Affected
0
num At Risk
155
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
317
group Id
EG001
num Affected
0
num At Risk
155
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
8
num At Risk
317
group Id
EG001
num Affected
3
num At Risk
155
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
317
group Id
EG001
num Affected
0
num At Risk
155
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
4
num At Risk
317
group Id
EG001
num Affected
2
num At Risk
155
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
317
group Id
EG001
num Affected
0
num At Risk
155
term
Acute myocardial infarction

time Frame

Up to 34 months plus 30 days

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Preserved source evidence · Not medical advice