NCT01539512 · ADVERSE EVENTS

Adverse events

A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) · Source last updated 2019-05-14

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: During study treatment plus 30 days (up to 2 years)
Other-event reporting threshold: 5%

Safety Analysis Set: randomized participants who received at least 1 dose of study drug, 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 + Rituximab Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)	65 / 110	103 / 110	Not reported / Not reported
Placebo + Rituximab Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)	43 / 108	102 / 108	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 (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
108
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
5
num At Risk
110
group Id
EG001
num Affected
6
num At Risk
108
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
0
num At Risk
108
term
Haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
3
num At Risk
110
group Id
EG001
num Affected
0
num At Risk
108
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
108
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
108
term
Splenic infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
108
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
0
num At Risk
108
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
108
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
0
num At Risk
108
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
108
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
108
term
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 (17.0)
stats
group Id
EG000
num Affected
13
num At Risk
110
group Id
EG001
num Affected
11
num At Risk
108
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
28
num At Risk
110
group Id
EG001
num Affected
21
num At Risk
108
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
8
num At Risk
110
group Id
EG001
num Affected
4
num At Risk
108
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
2
num At Risk
110
group Id
EG001
num Affected
6
num At Risk
108
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
9
num At Risk
110
group Id
EG001
num Affected
11
num At Risk
108
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
8
num At Risk
110
group Id
EG001
num Affected
3
num At Risk
108
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
6
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
108
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
16
num At Risk
110
group Id
EG001
num Affected
15
num At Risk
108
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
31
num At Risk
110
group Id
EG001
num Affected
19
num At Risk
108
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
11
num At Risk
110
group Id
EG001
num Affected
0
num At Risk
108
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
30
num At Risk
110
group Id
EG001
num Affected
25
num At Risk
108
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
7
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
108
term
Stomatitis

Complete source fields

description

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

event Groups

description
Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
id
EG000
other Num Affected
103
other Num At Risk
110
serious Num Affected
65
serious Num At Risk
110
title
Idelalisib + Rituximab
description
Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
id
EG001
other Num Affected
102
other Num At Risk
108
serious Num Affected
43
serious Num At Risk
108
title
Placebo + Rituximab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
13
num At Risk
110
group Id
EG001
num Affected
11
num At Risk
108
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
28
num At Risk
110
group Id
EG001
num Affected
21
num At Risk
108
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
8
num At Risk
110
group Id
EG001
num Affected
4
num At Risk
108
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
2
num At Risk
110
group Id
EG001
num Affected
6
num At Risk
108
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
9
num At Risk
110
group Id
EG001
num Affected
11
num At Risk
108
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
8
num At Risk
110
group Id
EG001
num Affected
3
num At Risk
108
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
6
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
108
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
16
num At Risk
110
group Id
EG001
num Affected
15
num At Risk
108
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
31
num At Risk
110
group Id
EG001
num Affected
19
num At Risk
108
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
11
num At Risk
110
group Id
EG001
num Affected
0
num At Risk
108
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
30
num At Risk
110
group Id
EG001
num Affected
25
num At Risk
108
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
7
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
108
term
Stomatitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
108
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
5
num At Risk
110
group Id
EG001
num Affected
6
num At Risk
108
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
0
num At Risk
108
term
Haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
3
num At Risk
110
group Id
EG001
num Affected
0
num At Risk
108
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
108
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
108
term
Splenic infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
108
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
0
num At Risk
108
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
108
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
0
num At Risk
108
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
108
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.0)
stats
group Id
EG000
num Affected
0
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
108
term
Myocardial infarction

time Frame

During study treatment plus 30 days (up to 2 years)

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Preserved source evidence · Not medical advice