NCT01732913 · ADVERSE EVENTS

Adverse events

Efficacy and Safety of Idelalisib (GS-1101) in Combination With 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 27 months plus 30 days
Other-event reporting threshold: 5%

Safety Analysis Set

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Idelalisib + Rituximab Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions	103 / 198	189 / 198	Not reported / Not reported
Placebo + Rituximab Placebo tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions	11 / 95	83 / 95	Not reported / Not reported

Group identifiers: EG000: Idelalisib + Rituximab · EG001: Placebo + 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
1
num At Risk
198
group Id
EG001
num Affected
0
num At Risk
95
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
7
num At Risk
198
group Id
EG001
num Affected
0
num At Risk
95
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
1
num At Risk
198
group Id
EG001
num Affected
0
num At Risk
95
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
3
num At Risk
198
group Id
EG001
num Affected
0
num At Risk
95
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
198
group Id
EG001
num Affected
1
num At Risk
95
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
198
group Id
EG001
num Affected
0
num At Risk
95
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
198
group Id
EG001
num Affected
0
num At Risk
95
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
198
group Id
EG001
num Affected
1
num At Risk
95
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
198
group Id
EG001
num Affected
0
num At Risk
95
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
198
group Id
EG001
num Affected
2
num At Risk
95
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
198
group Id
EG001
num Affected
0
num At Risk
95
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
198
group Id
EG001
num Affected
0
num At Risk
95
term
Tachycardia

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
12
num At Risk
198
group Id
EG001
num Affected
6
num At Risk
95
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
25
num At Risk
198
group Id
EG001
num Affected
5
num At Risk
95
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
20
num At Risk
198
group Id
EG001
num Affected
4
num At Risk
95
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
28
num At Risk
198
group Id
EG001
num Affected
13
num At Risk
95
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
88
num At Risk
198
group Id
EG001
num Affected
18
num At Risk
95
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
10
num At Risk
198
group Id
EG001
num Affected
3
num At Risk
95
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
50
num At Risk
198
group Id
EG001
num Affected
12
num At Risk
95
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
29
num At Risk
198
group Id
EG001
num Affected
7
num At Risk
95
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
15
num At Risk
198
group Id
EG001
num Affected
9
num At Risk
95
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
11
num At Risk
198
group Id
EG001
num Affected
4
num At Risk
95
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
41
num At Risk
198
group Id
EG001
num Affected
20
num At Risk
95
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
14
num At Risk
198
group Id
EG001
num Affected
5
num At Risk
95
term
Oedema peripheral

Complete source fields

description

Safety Analysis Set

event Groups

description
Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions
id
EG000
other Num Affected
189
other Num At Risk
198
serious Num Affected
103
serious Num At Risk
198
title
Idelalisib + Rituximab
description
Placebo tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions
id
EG001
other Num Affected
83
other Num At Risk
95
serious Num Affected
11
serious Num At Risk
95
title
Placebo + 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
12
num At Risk
198
group Id
EG001
num Affected
6
num At Risk
95
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
25
num At Risk
198
group Id
EG001
num Affected
5
num At Risk
95
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
20
num At Risk
198
group Id
EG001
num Affected
4
num At Risk
95
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
28
num At Risk
198
group Id
EG001
num Affected
13
num At Risk
95
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
88
num At Risk
198
group Id
EG001
num Affected
18
num At Risk
95
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
10
num At Risk
198
group Id
EG001
num Affected
3
num At Risk
95
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
50
num At Risk
198
group Id
EG001
num Affected
12
num At Risk
95
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
29
num At Risk
198
group Id
EG001
num Affected
7
num At Risk
95
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
15
num At Risk
198
group Id
EG001
num Affected
9
num At Risk
95
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
11
num At Risk
198
group Id
EG001
num Affected
4
num At Risk
95
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
41
num At Risk
198
group Id
EG001
num Affected
20
num At Risk
95
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
14
num At Risk
198
group Id
EG001
num Affected
5
num At Risk
95
term
Oedema peripheral

serious Events

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
198
group Id
EG001
num Affected
0
num At Risk
95
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
7
num At Risk
198
group Id
EG001
num Affected
0
num At Risk
95
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
1
num At Risk
198
group Id
EG001
num Affected
0
num At Risk
95
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
3
num At Risk
198
group Id
EG001
num Affected
0
num At Risk
95
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
198
group Id
EG001
num Affected
1
num At Risk
95
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
198
group Id
EG001
num Affected
0
num At Risk
95
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
198
group Id
EG001
num Affected
0
num At Risk
95
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
198
group Id
EG001
num Affected
1
num At Risk
95
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
198
group Id
EG001
num Affected
0
num At Risk
95
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
198
group Id
EG001
num Affected
2
num At Risk
95
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
198
group Id
EG001
num Affected
0
num At Risk
95
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
198
group Id
EG001
num Affected
0
num At Risk
95
term
Tachycardia

time Frame

Up to 27 months plus 30 days

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Preserved source evidence · Not medical advice