NCT01776840 · 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
- All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months
- Other-event reporting threshold
- 5%
All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Placebo + Bendamustine and Rituximab (BR) (Treatment A) | 157 / 260 | 255 / 260 | 129 / 262 |
| Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) | 201 / 259 | 256 / 259 | 120 / 261 |
Serious adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 259
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 259
- term
- Febrile Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 259
- term
- Leukocytosis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 259
- term
- Lymphadenitis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 259
- term
- Methaemoglobinaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 259
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 259
- term
- Pancytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 259
- term
- Splenic Infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 259
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 259
- term
- Acute Coronary Syndrome
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 259
- term
- Acute Myocardial Infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 259
- term
- Angina Pectoris
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 60
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 83
- num At Risk
- 259
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 27
- num At Risk
- 259
- term
- Leukopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 18
- num At Risk
- 259
- term
- Lymphopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 104
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 109
- num At Risk
- 259
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 43
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 62
- num At Risk
- 259
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 32
- num At Risk
- 259
- term
- Atrial Fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 259
- term
- Palpitations
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 11
- num At Risk
- 259
- term
- Vertigo
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 21
- num At Risk
- 259
- term
- Cataract
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 259
- term
- Dry Eye
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 14
- num At Risk
- 259
- term
- Vision Blurred
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 29
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 25
- num At Risk
- 259
- term
- Abdominal Pain
Complete source fields
- description
- All-cause mortality: All randomized participants. SAEs and Non SAEs: Safety analysis set included all randomized participants who received at least 1 dose of study drug (ibrutinib or placebo).
- event Groups
- deaths Num Affected
- 129
- deaths Num At Risk
- 262
- description
- Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.
- id
- EG000
- other Num Affected
- 255
- other Num At Risk
- 260
- serious Num Affected
- 157
- serious Num At Risk
- 260
- title
- Placebo + Bendamustine and Rituximab (BR) (Treatment A)
- deaths Num Affected
- 120
- deaths Num At Risk
- 261
- description
- Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
- id
- EG001
- other Num Affected
- 256
- other Num At Risk
- 259
- serious Num Affected
- 201
- serious Num At Risk
- 259
- title
- Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B)
- frequency Threshold
- 5
- other Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 60
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 83
- num At Risk
- 259
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 27
- num At Risk
- 259
- term
- Leukopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 18
- num At Risk
- 259
- term
- Lymphopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 104
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 109
- num At Risk
- 259
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 43
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 62
- num At Risk
- 259
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 32
- num At Risk
- 259
- term
- Atrial Fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 259
- term
- Palpitations
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 11
- num At Risk
- 259
- term
- Vertigo
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 21
- num At Risk
- 259
- term
- Cataract
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 259
- term
- Dry Eye
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 14
- num At Risk
- 259
- term
- Vision Blurred
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 29
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 25
- num At Risk
- 259
- term
- Abdominal Pain
- serious Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 259
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 259
- term
- Febrile Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 259
- term
- Leukocytosis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 259
- term
- Lymphadenitis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 259
- term
- Methaemoglobinaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 259
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 259
- term
- Pancytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 259
- term
- Splenic Infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 259
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 259
- term
- Acute Coronary Syndrome
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 259
- term
- Acute Myocardial Infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 260
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 259
- term
- Angina Pectoris
- time Frame
- All-cause mortality: From randomization (Day -3) up to 121 months; SAEs and Non SAEs: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle