NCT01311687 · 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 first dose of study drug through to 30 days after the last dose as of the end of the study (29 August 2017); maximum time on treatment was 297, 269, and 239 weeks in the Pomalidomide + LD-Dex, HD-Dex, and cross-over groups respectively.
- Other-event reporting threshold
- 5%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 195 / 300 | 291 / 300 | 252 / 300 |
| High-Dose Dexamethasone | 80 / 150 | 143 / 150 | 124 / 150 |
| HD-Dex / Pomalidomide | 4 / 11 | 11 / 11 | 8 / 11 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Blood disorder
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 19
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Haemorrhagic anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Hyperviscosity syndrome
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Pancytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Angina pectoris
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Atrial flutter
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Atrial tachycardia
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 159
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 77
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 11
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 40
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Lymphopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 155
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 30
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 11
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 87
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 42
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 11
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 11
- term
- Palpitations
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 11
- term
- Ear pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 11
- term
- Adrenal insufficiency
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 11
- term
- Cataract
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 11
- term
- Macular pigmentation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 11
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 72
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 22
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 11
- term
- Constipation
Complete source fields
- event Groups
- deaths Num Affected
- 252
- deaths Num At Risk
- 300
- description
- Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
- id
- EG000
- other Num Affected
- 291
- other Num At Risk
- 300
- serious Num Affected
- 195
- serious Num At Risk
- 300
- title
- Pomalidomide Plus Low-Dose Dexamethasone
- deaths Num Affected
- 124
- deaths Num At Risk
- 150
- description
- Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression, or until cross-over to pomalidomide. Data are up to the time of cross-over.
- id
- EG001
- other Num Affected
- 143
- other Num At Risk
- 150
- serious Num Affected
- 80
- serious Num At Risk
- 150
- title
- High-Dose Dexamethasone
- deaths Num Affected
- 8
- deaths Num At Risk
- 11
- description
- Participants initially randomized to high-dose dexamethasone (HD-Dex) crossed over to receive 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle, with or without low-dose dexamethasone (40 mg for participants ≤ 75 years or 20 mg for participants \> 75 years of age, administered orally once per day on Days 1, 8, 15, and 22 of each 28-day cycle) at the discretion of the investigator. Data include AEs that occurred after cross-over to pomalidomide.
- id
- EG002
- other Num Affected
- 11
- other Num At Risk
- 11
- serious Num Affected
- 4
- serious Num At Risk
- 11
- title
- HD-Dex / Pomalidomide
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 159
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 77
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 11
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 40
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Lymphopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 155
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 30
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 11
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 87
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 42
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 11
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 11
- term
- Palpitations
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 11
- term
- Ear pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 11
- term
- Adrenal insufficiency
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 11
- term
- Cataract
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 11
- term
- Macular pigmentation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 11
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 72
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 22
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 11
- term
- Constipation
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Blood disorder
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 19
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Haemorrhagic anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Hyperviscosity syndrome
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Pancytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Angina pectoris
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Atrial flutter
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 19
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 300
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 150
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 11
- term
- Atrial tachycardia
- time Frame
- From first dose of study drug through to 30 days after the last dose as of the end of the study (29 August 2017); maximum time on treatment was 297, 269, and 239 weeks in the Pomalidomide + LD-Dex, HD-Dex, and cross-over groups respectively.
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