NCT02005471 · 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
- From signing of informed consent form up to approximately 8 years 5 months
- Other-event reporting threshold
- 5%
SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Bendamustine + Rituximab Main Study | 84 / 188 | 177 / 188 | 84 / 188 |
| Venetoclax + Rituximab Main Study | 101 / 194 | 190 / 194 | 60 / 194 |
| Bendamustine + Rituximab Crossover Substudy | 5 / 9 | 5 / 9 | 1 / 9 |
| Venetoclax + Rituximab Re-Treatment Substudy | 13 / 25 | 9 / 25 | 8 / 25 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 188
- num Events
- 6
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 194
- num Events
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 25
- num Events
- 1
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 188
- num Events
- 4
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 194
- num Events
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Autoimmune haemolytic anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 188
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 194
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Disseminated intravascular coagulation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 188
- num Events
- 16
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 194
- num Events
- 7
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 25
- num Events
- 1
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 188
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 194
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Leukocytosis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 188
- num Events
- 3
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 194
- num Events
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 9
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 188
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 194
- num Events
- 2
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Pancytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 188
- num Events
- 2
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 194
- num Events
- 2
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 188
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 194
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Acute myocardial infarction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 188
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 194
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Angina pectoris
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 188
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 194
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 188
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 194
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Cardiac failure
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 40
- num At Risk
- 188
- num Events
- 68
- group Id
- EG001
- num Affected
- 28
- num At Risk
- 194
- num Events
- 48
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 9
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 25
- num Events
- 1
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 84
- num At Risk
- 188
- num Events
- 182
- group Id
- EG001
- num Affected
- 120
- num At Risk
- 194
- num Events
- 290
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 9
- num Events
- 5
- group Id
- EG003
- num Affected
- 5
- num At Risk
- 25
- num Events
- 13
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 42
- num At Risk
- 188
- num Events
- 57
- group Id
- EG001
- num Affected
- 23
- num At Risk
- 194
- num Events
- 30
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 25
- num Events
- 2
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 188
- num Events
- 7
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 194
- num Events
- 14
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 39
- num At Risk
- 188
- num Events
- 47
- group Id
- EG001
- num Affected
- 27
- num At Risk
- 194
- num Events
- 31
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 31
- num At Risk
- 188
- num Events
- 43
- group Id
- EG001
- num Affected
- 78
- num At Risk
- 194
- num Events
- 120
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 25
- num Events
- 4
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 64
- num At Risk
- 188
- num Events
- 82
- group Id
- EG001
- num Affected
- 42
- num At Risk
- 194
- num Events
- 58
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 22
- num At Risk
- 188
- num Events
- 29
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 194
- num Events
- 18
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 188
- num Events
- 14
- group Id
- EG001
- num Affected
- 20
- num At Risk
- 194
- num Events
- 32
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 25
- num Events
- 1
- term
- Bronchitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 188
- num Events
- 5
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 194
- num Events
- 11
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Conjunctivitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 188
- num Events
- 4
- group Id
- EG001
- num Affected
- 11
- num At Risk
- 194
- num Events
- 15
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Lower respiratory tract infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 11
- num At Risk
- 188
- num Events
- 15
- group Id
- EG001
- num Affected
- 22
- num At Risk
- 194
- num Events
- 29
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Nasopharyngitis
Complete source fields
- description
- SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
- event Groups
- deaths Num Affected
- 84
- deaths Num At Risk
- 188
- description
- Participants received bendamustine at a dose of 70 mg/m\^2 via IV infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
- id
- EG000
- other Num Affected
- 177
- other Num At Risk
- 188
- serious Num Affected
- 84
- serious Num At Risk
- 188
- title
- Bendamustine + Rituximab Main Study
- deaths Num Affected
- 60
- deaths Num At Risk
- 194
- description
- Participants were initially placed on a venetoclax ramp-up period of 5 weeks, and received an initial dose of 20 mg via tablet orally QD for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg via tablet orally QD. Participants continued receiving venetoclax at a dose of 400 mg via tablet orally QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
- id
- EG001
- other Num Affected
- 190
- other Num At Risk
- 194
- serious Num Affected
- 101
- serious Num At Risk
- 194
- title
- Venetoclax + Rituximab Main Study
- deaths Num Affected
- 1
- deaths Num At Risk
- 9
- description
- Participants who entered the crossover substudy had a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, participants received 6 cycles of rituximab, 375 mg/m\^2, as IV infusion on the Day 1 of each 28-day cycle. Participants who did not progress following the completion of the 6 cycles continued to receive venetoclax monotherapy until disease progression or for a maximum of 2 years from Cycle 1 crossover Day 1 of the substudy.
- id
- EG002
- other Num Affected
- 5
- other Num At Risk
- 9
- serious Num Affected
- 5
- serious Num At Risk
- 9
- title
- Bendamustine + Rituximab Crossover Substudy
- deaths Num Affected
- 8
- deaths Num At Risk
- 25
- description
- Participants who entered the re-treatment substudy had a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, participants received 6 cycles of rituximab consisting of a single infusion on the first day of each 28-day cycle. Participants who did not progress following the completion of the 6 cycles continued to receive venetoclax monotherapy until disease progression or for a maximum of 2 year from Cycle 1 re-treatment Day 1 of the substudy.
- id
- EG003
- other Num Affected
- 9
- other Num At Risk
- 25
- serious Num Affected
- 13
- serious Num At Risk
- 25
- title
- Venetoclax + Rituximab Re-Treatment Substudy
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 40
- num At Risk
- 188
- num Events
- 68
- group Id
- EG001
- num Affected
- 28
- num At Risk
- 194
- num Events
- 48
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 9
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 25
- num Events
- 1
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 84
- num At Risk
- 188
- num Events
- 182
- group Id
- EG001
- num Affected
- 120
- num At Risk
- 194
- num Events
- 290
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 9
- num Events
- 5
- group Id
- EG003
- num Affected
- 5
- num At Risk
- 25
- num Events
- 13
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 42
- num At Risk
- 188
- num Events
- 57
- group Id
- EG001
- num Affected
- 23
- num At Risk
- 194
- num Events
- 30
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 25
- num Events
- 2
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 188
- num Events
- 7
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 194
- num Events
- 14
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 39
- num At Risk
- 188
- num Events
- 47
- group Id
- EG001
- num Affected
- 27
- num At Risk
- 194
- num Events
- 31
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 31
- num At Risk
- 188
- num Events
- 43
- group Id
- EG001
- num Affected
- 78
- num At Risk
- 194
- num Events
- 120
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 25
- num Events
- 4
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 64
- num At Risk
- 188
- num Events
- 82
- group Id
- EG001
- num Affected
- 42
- num At Risk
- 194
- num Events
- 58
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 22
- num At Risk
- 188
- num Events
- 29
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 194
- num Events
- 18
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 188
- num Events
- 14
- group Id
- EG001
- num Affected
- 20
- num At Risk
- 194
- num Events
- 32
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 25
- num Events
- 1
- term
- Bronchitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 188
- num Events
- 5
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 194
- num Events
- 11
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Conjunctivitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 188
- num Events
- 4
- group Id
- EG001
- num Affected
- 11
- num At Risk
- 194
- num Events
- 15
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Lower respiratory tract infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 11
- num At Risk
- 188
- num Events
- 15
- group Id
- EG001
- num Affected
- 22
- num At Risk
- 194
- num Events
- 29
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Nasopharyngitis
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 188
- num Events
- 6
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 194
- num Events
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 25
- num Events
- 1
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 188
- num Events
- 4
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 194
- num Events
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Autoimmune haemolytic anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 188
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 194
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Disseminated intravascular coagulation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 188
- num Events
- 16
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 194
- num Events
- 7
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 25
- num Events
- 1
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 188
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 194
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Leukocytosis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 188
- num Events
- 3
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 194
- num Events
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 9
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 188
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 194
- num Events
- 2
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Pancytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 188
- num Events
- 2
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 194
- num Events
- 2
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 188
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 194
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Acute myocardial infarction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 188
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 194
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Angina pectoris
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 188
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 194
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 188
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 194
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- term
- Cardiac failure
- time Frame
- From signing of informed consent form up to approximately 8 years 5 months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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