NCT01010061 · ADVERSE EVENTS

Adverse events

CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a) · Source last updated 2018-09-14

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: Randomization to clinical cutoff (median observation 42 months)
Other-event reporting threshold: 5%

Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Obinutuzumab + Chlorambucil (GClb) Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).	113 / 241	215 / 241	Not reported / Not reported
Chlorambucil (Clb) Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.	45 / 116	89 / 116	Not reported / Not reported
Crossover Subjects: Obinutuzumab + Chlorambucil (GClb) Subjects in Clb arm who progressed during/within 6 months after end of Clb treatment had opportunity to cross over to GClb arm at discretion of investigator. Subjects received 1000 mg obinutuzumab IV infusion, on Day 1 \[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 milligram per kilogram of body weight (mg/kg) orally on Day 1 and 15 of each 28-day cycle (6 Cycles).	8 / 30	23 / 30	Not reported / Not reported

Group identifiers: EG000: Obinutuzumab + Chlorambucil (GClb) · EG001: Chlorambucil (Clb) · EG002: Crossover Subjects: Obinutuzumab + Chlorambucil (GClb)

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
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
10
num At Risk
241
group Id
EG001
num Affected
4
num At Risk
116
group Id
EG002
num Affected
1
num At Risk
30
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
241
group Id
EG001
num Affected
3
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
241
group Id
EG001
num Affected
2
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
3
num At Risk
241
group Id
EG001
num Affected
1
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
241
group Id
EG001
num Affected
2
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Erysipelas
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
241
group Id
EG001
num Affected
1
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
3
num At Risk
241
group Id
EG001
num Affected
0
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Neutropenic sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
241
group Id
EG001
num Affected
4
num At Risk
116
group Id
EG002
num Affected
1
num At Risk
30
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
241
group Id
EG001
num Affected
1
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
241
group Id
EG001
num Affected
1
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Liver abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
241
group Id
EG001
num Affected
1
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
241
group Id
EG001
num Affected
0
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Bronchitis

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 15.0
stats
group Id
EG000
num Affected
99
num At Risk
241
group Id
EG001
num Affected
21
num At Risk
116
group Id
EG002
num Affected
12
num At Risk
30
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
36
num At Risk
241
group Id
EG001
num Affected
9
num At Risk
116
group Id
EG002
num Affected
7
num At Risk
30
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
27
num At Risk
241
group Id
EG001
num Affected
12
num At Risk
116
group Id
EG002
num Affected
3
num At Risk
30
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
17
num At Risk
241
group Id
EG001
num Affected
0
num At Risk
116
group Id
EG002
num Affected
5
num At Risk
30
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
32
num At Risk
241
group Id
EG001
num Affected
29
num At Risk
116
group Id
EG002
num Affected
3
num At Risk
30
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
23
num At Risk
241
group Id
EG001
num Affected
13
num At Risk
116
group Id
EG002
num Affected
3
num At Risk
30
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
17
num At Risk
241
group Id
EG001
num Affected
12
num At Risk
116
group Id
EG002
num Affected
2
num At Risk
30
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
13
num At Risk
241
group Id
EG001
num Affected
14
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
147
num At Risk
241
group Id
EG001
num Affected
0
num At Risk
116
group Id
EG002
num Affected
15
num At Risk
30
term
Infusion related reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
25
num At Risk
241
group Id
EG001
num Affected
8
num At Risk
116
group Id
EG002
num Affected
2
num At Risk
30
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
16
num At Risk
241
group Id
EG001
num Affected
12
num At Risk
116
group Id
EG002
num Affected
1
num At Risk
30
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
17
num At Risk
241
group Id
EG001
num Affected
8
num At Risk
116
group Id
EG002
num Affected
1
num At Risk
30
term
Asthenia

Complete source fields

description

event Groups

description
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
id
EG000
other Num Affected
215
other Num At Risk
241
serious Num Affected
113
serious Num At Risk
241
title
Obinutuzumab + Chlorambucil (GClb)
description
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
id
EG001
other Num Affected
89
other Num At Risk
116
serious Num Affected
45
serious Num At Risk
116
title
Chlorambucil (Clb)
description
Subjects in Clb arm who progressed during/within 6 months after end of Clb treatment had opportunity to cross over to GClb arm at discretion of investigator. Subjects received 1000 mg obinutuzumab IV infusion, on Day 1 \[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 milligram per kilogram of body weight (mg/kg) orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
id
EG002
other Num Affected
23
other Num At Risk
30
serious Num Affected
8
serious Num At Risk
30
title
Crossover Subjects: Obinutuzumab + Chlorambucil (GClb)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
99
num At Risk
241
group Id
EG001
num Affected
21
num At Risk
116
group Id
EG002
num Affected
12
num At Risk
30
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
36
num At Risk
241
group Id
EG001
num Affected
9
num At Risk
116
group Id
EG002
num Affected
7
num At Risk
30
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
27
num At Risk
241
group Id
EG001
num Affected
12
num At Risk
116
group Id
EG002
num Affected
3
num At Risk
30
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
17
num At Risk
241
group Id
EG001
num Affected
0
num At Risk
116
group Id
EG002
num Affected
5
num At Risk
30
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
32
num At Risk
241
group Id
EG001
num Affected
29
num At Risk
116
group Id
EG002
num Affected
3
num At Risk
30
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
23
num At Risk
241
group Id
EG001
num Affected
13
num At Risk
116
group Id
EG002
num Affected
3
num At Risk
30
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
17
num At Risk
241
group Id
EG001
num Affected
12
num At Risk
116
group Id
EG002
num Affected
2
num At Risk
30
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
13
num At Risk
241
group Id
EG001
num Affected
14
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
147
num At Risk
241
group Id
EG001
num Affected
0
num At Risk
116
group Id
EG002
num Affected
15
num At Risk
30
term
Infusion related reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
25
num At Risk
241
group Id
EG001
num Affected
8
num At Risk
116
group Id
EG002
num Affected
2
num At Risk
30
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
16
num At Risk
241
group Id
EG001
num Affected
12
num At Risk
116
group Id
EG002
num Affected
1
num At Risk
30
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.0
stats
group Id
EG000
num Affected
17
num At Risk
241
group Id
EG001
num Affected
8
num At Risk
116
group Id
EG002
num Affected
1
num At Risk
30
term
Asthenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
10
num At Risk
241
group Id
EG001
num Affected
4
num At Risk
116
group Id
EG002
num Affected
1
num At Risk
30
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
241
group Id
EG001
num Affected
3
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
241
group Id
EG001
num Affected
2
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
3
num At Risk
241
group Id
EG001
num Affected
1
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
241
group Id
EG001
num Affected
2
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Erysipelas
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
241
group Id
EG001
num Affected
1
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
3
num At Risk
241
group Id
EG001
num Affected
0
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Neutropenic sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
241
group Id
EG001
num Affected
4
num At Risk
116
group Id
EG002
num Affected
1
num At Risk
30
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
241
group Id
EG001
num Affected
1
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
241
group Id
EG001
num Affected
1
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Liver abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
241
group Id
EG001
num Affected
1
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
241
group Id
EG001
num Affected
0
num At Risk
116
group Id
EG002
num Affected
0
num At Risk
30
term
Bronchitis

time Frame

Randomization to clinical cutoff (median observation 42 months)

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