NCT01980888 · ADVERSE EVENTS

Adverse events

Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia · Source last updated 2018-11-19

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 22 months plus 30 days
Other-event reporting threshold: 5%

Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Idelalisib+Bendamustine+Rituximab Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)	113 / 156	154 / 156	Not reported / Not reported
Placebo+Bendamustine+Rituximab Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)	68 / 154	150 / 154	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 Version 19.0
stats
group Id
EG000
num Affected
8
num At Risk
156
group Id
EG001
num Affected
2
num At Risk
154
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
1
num At Risk
156
group Id
EG001
num Affected
0
num At Risk
154
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
29
num At Risk
156
group Id
EG001
num Affected
16
num At Risk
154
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
1
num At Risk
156
group Id
EG001
num Affected
0
num At Risk
154
term
Haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
0
num At Risk
156
group Id
EG001
num Affected
1
num At Risk
154
term
Lymphadenopathy mediastinal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
7
num At Risk
156
group Id
EG001
num Affected
1
num At Risk
154
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
2
num At Risk
156
group Id
EG001
num Affected
1
num At Risk
154
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
0
num At Risk
156
group Id
EG001
num Affected
2
num At Risk
154
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
0
num At Risk
156
group Id
EG001
num Affected
1
num At Risk
154
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
4
num At Risk
156
group Id
EG001
num Affected
3
num At Risk
154
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
1
num At Risk
156
group Id
EG001
num Affected
2
num At Risk
154
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
0
num At Risk
156
group Id
EG001
num Affected
1
num At Risk
154
term
Cardiac failure chronic

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 19.0
stats
group Id
EG000
num Affected
40
num At Risk
156
group Id
EG001
num Affected
29
num At Risk
154
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
84
num At Risk
156
group Id
EG001
num Affected
90
num At Risk
154
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
19
num At Risk
156
group Id
EG001
num Affected
16
num At Risk
154
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
8
num At Risk
156
group Id
EG001
num Affected
3
num At Risk
154
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
14
num At Risk
156
group Id
EG001
num Affected
14
num At Risk
154
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
26
num At Risk
156
group Id
EG001
num Affected
34
num At Risk
154
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
63
num At Risk
156
group Id
EG001
num Affected
46
num At Risk
154
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
11
num At Risk
156
group Id
EG001
num Affected
4
num At Risk
154
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
15
num At Risk
156
group Id
EG001
num Affected
12
num At Risk
154
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
9
num At Risk
156
group Id
EG001
num Affected
4
num At Risk
154
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
61
num At Risk
156
group Id
EG001
num Affected
63
num At Risk
154
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
10
num At Risk
156
group Id
EG001
num Affected
4
num At Risk
154
term
Stomatitis

Complete source fields

description

Safety Analysis Set: participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.

event Groups

description
Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
id
EG000
other Num Affected
154
other Num At Risk
156
serious Num Affected
113
serious Num At Risk
156
title
Idelalisib+Bendamustine+Rituximab
description
Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
id
EG001
other Num Affected
150
other Num At Risk
154
serious Num Affected
68
serious Num At Risk
154
title
Placebo+Bendamustine+Rituximab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
40
num At Risk
156
group Id
EG001
num Affected
29
num At Risk
154
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
84
num At Risk
156
group Id
EG001
num Affected
90
num At Risk
154
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
19
num At Risk
156
group Id
EG001
num Affected
16
num At Risk
154
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
8
num At Risk
156
group Id
EG001
num Affected
3
num At Risk
154
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
14
num At Risk
156
group Id
EG001
num Affected
14
num At Risk
154
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
26
num At Risk
156
group Id
EG001
num Affected
34
num At Risk
154
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
63
num At Risk
156
group Id
EG001
num Affected
46
num At Risk
154
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
11
num At Risk
156
group Id
EG001
num Affected
4
num At Risk
154
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
15
num At Risk
156
group Id
EG001
num Affected
12
num At Risk
154
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
9
num At Risk
156
group Id
EG001
num Affected
4
num At Risk
154
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
61
num At Risk
156
group Id
EG001
num Affected
63
num At Risk
154
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
10
num At Risk
156
group Id
EG001
num Affected
4
num At Risk
154
term
Stomatitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
8
num At Risk
156
group Id
EG001
num Affected
2
num At Risk
154
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
1
num At Risk
156
group Id
EG001
num Affected
0
num At Risk
154
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
29
num At Risk
156
group Id
EG001
num Affected
16
num At Risk
154
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
1
num At Risk
156
group Id
EG001
num Affected
0
num At Risk
154
term
Haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
0
num At Risk
156
group Id
EG001
num Affected
1
num At Risk
154
term
Lymphadenopathy mediastinal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
7
num At Risk
156
group Id
EG001
num Affected
1
num At Risk
154
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
2
num At Risk
156
group Id
EG001
num Affected
1
num At Risk
154
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
0
num At Risk
156
group Id
EG001
num Affected
2
num At Risk
154
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
0
num At Risk
156
group Id
EG001
num Affected
1
num At Risk
154
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
4
num At Risk
156
group Id
EG001
num Affected
3
num At Risk
154
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
1
num At Risk
156
group Id
EG001
num Affected
2
num At Risk
154
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.0
stats
group Id
EG000
num Affected
0
num At Risk
156
group Id
EG001
num Affected
1
num At Risk
154
term
Cardiac failure chronic

time Frame

Up to 22 months plus 30 days

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Preserved source evidence · Not medical advice