NCT02004522 · ADVERSE EVENTS

Adverse events

A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO) · Source last updated 2023-09-21

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: 39 months
Other-event reporting threshold: 5%

Safety data rerun to include treatment-emergent adverse events that occurred on Day 1.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Duvelisib Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.	124 / 158	149 / 158	78 / 158
Ofatumumab Ofatumumab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.	50 / 155	130 / 155	70 / 155

Group identifiers: EG000: Duvelisib · EG001: Ofatumumab

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 16.1
stats
group Id
EG000
num Affected
10
num At Risk
158
group Id
EG001
num Affected
3
num At Risk
155
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
2
num At Risk
158
group Id
EG001
num Affected
2
num At Risk
155
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
2
num At Risk
158
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 version 16.1
stats
group Id
EG000
num Affected
3
num At Risk
158
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 version 16.1
stats
group Id
EG000
num Affected
1
num At Risk
158
group Id
EG001
num Affected
0
num At Risk
155
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
1
num At Risk
158
group Id
EG001
num Affected
0
num At Risk
155
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
0
num At Risk
158
group Id
EG001
num Affected
1
num At Risk
155
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
2
num At Risk
158
group Id
EG001
num Affected
1
num At Risk
155
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
3
num At Risk
158
group Id
EG001
num Affected
1
num At Risk
155
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
2
num At Risk
158
group Id
EG001
num Affected
0
num At Risk
155
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
1
num At Risk
158
group Id
EG001
num Affected
0
num At Risk
155
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
1
num At Risk
158
group Id
EG001
num Affected
0
num At Risk
155
term
Pericarditis

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 16.1
stats
group Id
EG000
num Affected
53
num At Risk
158
group Id
EG001
num Affected
32
num At Risk
155
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
39
num At Risk
158
group Id
EG001
num Affected
16
num At Risk
155
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
27
num At Risk
158
group Id
EG001
num Affected
9
num At Risk
155
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
79
num At Risk
158
group Id
EG001
num Affected
19
num At Risk
155
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
38
num At Risk
158
group Id
EG001
num Affected
17
num At Risk
155
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
27
num At Risk
158
group Id
EG001
num Affected
12
num At Risk
155
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
23
num At Risk
158
group Id
EG001
num Affected
10
num At Risk
155
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
17
num At Risk
158
group Id
EG001
num Affected
3
num At Risk
155
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
9
num At Risk
158
group Id
EG001
num Affected
4
num At Risk
155
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
9
num At Risk
158
group Id
EG001
num Affected
5
num At Risk
155
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
0
num At Risk
158
group Id
EG001
num Affected
10
num At Risk
155
term
Paraesthesia oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
8
num At Risk
158
group Id
EG001
num Affected
1
num At Risk
155
term
Colitis

Complete source fields

description

Safety data rerun to include treatment-emergent adverse events that occurred on Day 1.

event Groups

deaths Num Affected
78
deaths Num At Risk
158
description
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.
id
EG000
other Num Affected
149
other Num At Risk
158
serious Num Affected
124
serious Num At Risk
158
title
Duvelisib
deaths Num Affected
70
deaths Num At Risk
155
description
Ofatumumab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
id
EG001
other Num Affected
130
other Num At Risk
155
serious Num Affected
50
serious Num At Risk
155
title
Ofatumumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
53
num At Risk
158
group Id
EG001
num Affected
32
num At Risk
155
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
39
num At Risk
158
group Id
EG001
num Affected
16
num At Risk
155
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
27
num At Risk
158
group Id
EG001
num Affected
9
num At Risk
155
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
79
num At Risk
158
group Id
EG001
num Affected
19
num At Risk
155
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
38
num At Risk
158
group Id
EG001
num Affected
17
num At Risk
155
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
27
num At Risk
158
group Id
EG001
num Affected
12
num At Risk
155
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
23
num At Risk
158
group Id
EG001
num Affected
10
num At Risk
155
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
17
num At Risk
158
group Id
EG001
num Affected
3
num At Risk
155
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
9
num At Risk
158
group Id
EG001
num Affected
4
num At Risk
155
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
9
num At Risk
158
group Id
EG001
num Affected
5
num At Risk
155
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
0
num At Risk
158
group Id
EG001
num Affected
10
num At Risk
155
term
Paraesthesia oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
8
num At Risk
158
group Id
EG001
num Affected
1
num At Risk
155
term
Colitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
10
num At Risk
158
group Id
EG001
num Affected
3
num At Risk
155
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
2
num At Risk
158
group Id
EG001
num Affected
2
num At Risk
155
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
2
num At Risk
158
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 version 16.1
stats
group Id
EG000
num Affected
3
num At Risk
158
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 version 16.1
stats
group Id
EG000
num Affected
1
num At Risk
158
group Id
EG001
num Affected
0
num At Risk
155
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
1
num At Risk
158
group Id
EG001
num Affected
0
num At Risk
155
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
0
num At Risk
158
group Id
EG001
num Affected
1
num At Risk
155
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
2
num At Risk
158
group Id
EG001
num Affected
1
num At Risk
155
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
3
num At Risk
158
group Id
EG001
num Affected
1
num At Risk
155
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
2
num At Risk
158
group Id
EG001
num Affected
0
num At Risk
155
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
1
num At Risk
158
group Id
EG001
num Affected
0
num At Risk
155
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 16.1
stats
group Id
EG000
num Affected
1
num At Risk
158
group Id
EG001
num Affected
0
num At Risk
155
term
Pericarditis

time Frame

39 months

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Preserved source evidence · Not medical advice