NCT04447027 · 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 was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide | 0 / 2 | 2 / 2 | 2 / 2 |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide | 2 / 6 | 6 / 6 | 3 / 6 |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide | 1 / 6 | 6 / 6 | 3 / 6 |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation | 2 / 3 | 3 / 3 | 1 / 3 |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide | 0 / 3 | 3 / 3 | 0 / 3 |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide | 0 / 2 | 2 / 2 | 1 / 2 |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide | 0 / 1 | 1 / 1 | 1 / 1 |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide | 0 / 3 | 3 / 3 | 0 / 3 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Adrenal insufficiency
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 2
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Blood bilirubin increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Heart failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Hepatobiliary disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Hepatobiliary disorders - Other, specify: Drug-Induced Liver Injury
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Hypotension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- (incl cysts and polyps) - Other, specify: Tumor flare reaction
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Neoplasms benign, malignant and unspecified
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Pain in extremity
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 2
- num Events
- 2
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Acute kidney injury
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Adrenal insufficiency
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 2
- num Events
- 2
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 2
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 7
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Alanine aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 3
- num Events
- 2
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Alkaline phosphatase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 6
- num Events
- 2
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Allergic reaction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Anal hemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Anal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 10
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 6
- num Events
- 16
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 6
- num Events
- 10
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 3
- num Events
- 14
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 3
- num Events
- 3
- group Id
- EG005
- num Affected
- 2
- num At Risk
- 2
- num Events
- 5
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 1
- num Events
- 18
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 3
- num Events
- 5
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 2
- num Events
- 2
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 6
- num Events
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 3
- num Events
- 4
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 3
- num Events
- 2
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Anxiety
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Arthralgia
Complete source fields
- event Groups
- deaths Num Affected
- 2
- deaths Num At Risk
- 2
- description
- T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level-1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
- id
- EG000
- other Num Affected
- 2
- other Num At Risk
- 2
- serious Num Affected
- 0
- serious Num At Risk
- 2
- title
- Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide
- deaths Num Affected
- 3
- deaths Num At Risk
- 6
- description
- T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
- id
- EG001
- other Num Affected
- 6
- other Num At Risk
- 6
- serious Num Affected
- 2
- serious Num At Risk
- 6
- title
- Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide
- deaths Num Affected
- 3
- deaths Num At Risk
- 6
- description
- T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
- id
- EG002
- other Num Affected
- 6
- other Num At Risk
- 6
- serious Num Affected
- 1
- serious Num At Risk
- 6
- title
- Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide
- deaths Num Affected
- 1
- deaths Num At Risk
- 3
- description
- T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
- id
- EG003
- other Num Affected
- 3
- other Num At Risk
- 3
- serious Num Affected
- 2
- serious Num At Risk
- 3
- title
- Arm 1, Cohort 1, Dose Level 3 Dose Escalation
- deaths Num Affected
- 0
- deaths Num At Risk
- 3
- description
- T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
- id
- EG004
- other Num Affected
- 3
- other Num At Risk
- 3
- serious Num Affected
- 0
- serious Num At Risk
- 3
- title
- Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide
- deaths Num Affected
- 1
- deaths Num At Risk
- 2
- description
- T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
- id
- EG005
- other Num Affected
- 2
- other Num At Risk
- 2
- serious Num Affected
- 0
- serious Num At Risk
- 2
- title
- Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide
- deaths Num Affected
- 1
- deaths Num At Risk
- 1
- description
- T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
- id
- EG006
- other Num Affected
- 1
- other Num At Risk
- 1
- serious Num Affected
- 0
- serious Num At Risk
- 1
- title
- Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
- deaths Num Affected
- 0
- deaths Num At Risk
- 3
- description
- T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
- id
- EG007
- other Num Affected
- 3
- other Num At Risk
- 3
- serious Num Affected
- 0
- serious Num At Risk
- 3
- title
- Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
- frequency Threshold
- 0
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 2
- num Events
- 2
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Acute kidney injury
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Adrenal insufficiency
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 2
- num Events
- 2
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 2
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 7
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Alanine aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 3
- num Events
- 2
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Alkaline phosphatase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 6
- num Events
- 2
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Allergic reaction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Anal hemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Anal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 10
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 6
- num Events
- 16
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 6
- num Events
- 10
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 3
- num Events
- 14
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 3
- num Events
- 3
- group Id
- EG005
- num Affected
- 2
- num At Risk
- 2
- num Events
- 5
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 1
- num Events
- 18
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 3
- num Events
- 5
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 2
- num Events
- 2
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 6
- num Events
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 3
- num Events
- 4
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 3
- num Events
- 2
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Anxiety
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Arthralgia
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Adrenal insufficiency
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 2
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Blood bilirubin increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Heart failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Hepatobiliary disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Hepatobiliary disorders - Other, specify: Drug-Induced Liver Injury
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Hypotension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- (incl cysts and polyps) - Other, specify: Tumor flare reaction
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Neoplasms benign, malignant and unspecified
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- term
- Pain in extremity
- time Frame
- All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle