NCT01478581 · 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
- Five Years
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Cohort 1 | 6 / 13 | 12 / 13 | 2 / 13 |
| Cohort 2 | 6 / 18 | 18 / 18 | 1 / 18 |
| Cohort 3 | 7 / 18 | 17 / 18 | 1 / 18 |
| Cohort 4 | 12 / 43 | 43 / 43 | 1 / 43 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 43
- term
- Pneumonia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 43
- term
- Clostridium difficile infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 43
- term
- Plasma cell myeloma
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 43
- term
- Syncope
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 43
- term
- Acute Kidney Injury
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 43
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 43
- term
- Aspergillus Infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 43
- term
- Atrial Fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 43
- term
- Bacterial Sepsis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 43
- term
- Bone Lesion
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 43
- term
- Bone Pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 43
- term
- Bronchopulmonary Aspergillosis
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 10
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 26
- num At Risk
- 43
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 21
- num At Risk
- 43
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 11
- num At Risk
- 43
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 6
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 12
- num At Risk
- 43
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 10
- num At Risk
- 43
- term
- Muscle Spasms
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 9
- num At Risk
- 43
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 12
- num At Risk
- 43
- term
- Cough
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 13
- num At Risk
- 43
- term
- Insomnia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 8
- num At Risk
- 43
- term
- Upper Respiratory Tract Infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 10
- num At Risk
- 43
- term
- Dizziness
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 11
- num At Risk
- 43
- term
- Pain In Extremity
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 43
- term
- Back Pain
Complete source fields
- event Groups
- deaths Num Affected
- 2
- deaths Num At Risk
- 13
- description
- PCI-32765 420 mg per day PCI-32765
- id
- EG000
- other Num Affected
- 12
- other Num At Risk
- 13
- serious Num Affected
- 6
- serious Num At Risk
- 13
- title
- Cohort 1
- deaths Num Affected
- 1
- deaths Num At Risk
- 18
- description
- PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
- id
- EG001
- other Num Affected
- 18
- other Num At Risk
- 18
- serious Num Affected
- 6
- serious Num At Risk
- 18
- title
- Cohort 2
- deaths Num Affected
- 1
- deaths Num At Risk
- 18
- description
- PCI-32765 840 mg per day PCI-32765
- id
- EG002
- other Num Affected
- 17
- other Num At Risk
- 18
- serious Num Affected
- 7
- serious Num At Risk
- 18
- title
- Cohort 3
- deaths Num Affected
- 1
- deaths Num At Risk
- 43
- description
- PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
- id
- EG003
- other Num Affected
- 43
- other Num At Risk
- 43
- serious Num Affected
- 12
- serious Num At Risk
- 43
- title
- Cohort 4
- frequency Threshold
- 0
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 10
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 26
- num At Risk
- 43
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 21
- num At Risk
- 43
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 11
- num At Risk
- 43
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 6
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 12
- num At Risk
- 43
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 10
- num At Risk
- 43
- term
- Muscle Spasms
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 9
- num At Risk
- 43
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 12
- num At Risk
- 43
- term
- Cough
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 13
- num At Risk
- 43
- term
- Insomnia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 8
- num At Risk
- 43
- term
- Upper Respiratory Tract Infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 10
- num At Risk
- 43
- term
- Dizziness
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 11
- num At Risk
- 43
- term
- Pain In Extremity
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 43
- term
- Back Pain
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 43
- term
- Pneumonia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 43
- term
- Clostridium difficile infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 43
- term
- Plasma cell myeloma
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 43
- term
- Syncope
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 43
- term
- Acute Kidney Injury
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 43
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 43
- term
- Aspergillus Infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 43
- term
- Atrial Fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 43
- term
- Bacterial Sepsis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 43
- term
- Bone Lesion
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 43
- term
- Bone Pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 18
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 43
- term
- Bronchopulmonary Aspergillosis
- time Frame
- Five Years
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle