NCT03462719 · ADVERSE EVENTS
Adverse events
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 4 years 10 months
- Other-event reporting threshold
- 5%
The safety analysis set is defined as all randomized participants who received at least one dose of any one of the four study drugs (ibrutinib, venetoclax, chlorambucil, or obinutuzumab).
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Treatment Arm A (Ibrutinib + Venetoclax) | 49 / 106 | 98 / 106 | 17 / 106 |
| Treatment Arm B (Chlorambucil + Obinutuzumab) | 30 / 105 | 98 / 105 | 36 / 105 |
Serious adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 105
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 105
- term
- Febrile Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 105
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 105
- term
- Acute Myocardial Infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 105
- term
- Angina Unstable
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 105
- term
- Atrial Fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 105
- term
- Cardiac Arrest
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 105
- term
- Cardiac Failure
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 105
- term
- Cardiac Failure Congestive
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 105
- term
- Myocardial Infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 105
- term
- Sinus Node Dysfunction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 105
- term
- Supraventricular Tachycardia
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 18
- num At Risk
- 105
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 105
- term
- Leukopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 36
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 56
- num At Risk
- 105
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 28
- num At Risk
- 105
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 105
- term
- Atrial Fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 105
- term
- Palpitations
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 105
- term
- Vertigo
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 105
- term
- Abdominal Pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 11
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 105
- term
- Constipation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 53
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 105
- term
- Diarrhoea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 105
- term
- Dyspepsia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 105
- term
- Mouth Ulceration
Complete source fields
- description
- The safety analysis set is defined as all randomized participants who received at least one dose of any one of the four study drugs (ibrutinib, venetoclax, chlorambucil, or obinutuzumab).
- event Groups
- deaths Num Affected
- 17
- deaths Num At Risk
- 106
- description
- Participants received ibrutinib 420 milligrams (mg) orally once daily for 3 cycles (each cycle is of 28 days) followed by the combination of ibrutinib 420 mg and venetoclax 400 mg orally once daily for 12 cycles (including a 5-week venetoclax dose ramp up starting in cycle 4). Participants who subsequently developed independent review committee (IRC)-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
- id
- EG000
- other Num Affected
- 98
- other Num At Risk
- 106
- serious Num Affected
- 49
- serious Num At Risk
- 106
- title
- Treatment Arm A (Ibrutinib + Venetoclax)
- deaths Num Affected
- 36
- deaths Num At Risk
- 105
- description
- Participants received chlorambucil 0.5 milligrams per kilogram (mg/kg) body weight orally once daily on Days 1 and 15 of Cycles 1 to 6 in combination with obinutuzumab 1000 mgs intravenously (IV) once daily on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (each cycle is of 28 days). Participants who subsequently developed IRC-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
- id
- EG001
- other Num Affected
- 98
- other Num At Risk
- 105
- serious Num Affected
- 30
- serious Num At Risk
- 105
- title
- Treatment Arm B (Chlorambucil + Obinutuzumab)
- frequency Threshold
- 5
- other Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 18
- num At Risk
- 105
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 105
- term
- Leukopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 36
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 56
- num At Risk
- 105
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 28
- num At Risk
- 105
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 105
- term
- Atrial Fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 105
- term
- Palpitations
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 105
- term
- Vertigo
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 105
- term
- Abdominal Pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 11
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 105
- term
- Constipation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 53
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 105
- term
- Diarrhoea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 105
- term
- Dyspepsia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 105
- term
- Mouth Ulceration
- serious Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 105
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 105
- term
- Febrile Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 105
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 105
- term
- Acute Myocardial Infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 105
- term
- Angina Unstable
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 105
- term
- Atrial Fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 105
- term
- Cardiac Arrest
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 105
- term
- Cardiac Failure
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 105
- term
- Cardiac Failure Congestive
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 105
- term
- Myocardial Infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 105
- term
- Sinus Node Dysfunction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 106
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 105
- term
- Supraventricular Tachycardia
- time Frame
- Up to 4 years 10 months
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Preserved source evidence · Not medical advice
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