NCT01947140 · 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
- up to 3 years
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Pralatrexate 10 mg/m2, Romidepsin 12mg/m2 | 0 / 3 | 3 / 3 | 0 / 3 |
| Phase 1 Schedule A: Pralatrexate 15 mg/m2, Romidepsin 12 mg/m2 | 1 / 3 | 3 / 3 | 1 / 3 |
| Phase 1 Schedule B: Pralatrexate 15 mg/m2, Romidepsin 12 mg/m2 | 0 / 3 | 3 / 3 | 0 / 3 |
| Phase 1 Schedule A: Pralatrexate 15 mg/m2, Romidepsin 14 mg/m2 | 1 / 3 | 3 / 3 | 0 / 3 |
| Phase 1 Schedule B: Pralatrexate 15 mg/m2, Romidepsin 14 mg/m2 | 1 / 3 | 3 / 3 | 2 / 3 |
| Phase 1 Schedule A: Pralatrexate 20 mg/m2, Romidepsin 12 mg/m2 | 2 / 5 | 5 / 5 | 0 / 5 |
| Phase 1 Schedule B: Pralatrexate 20 mg/m2, Romidepsin 12 mg/m2 | 1 / 3 | 3 / 3 | 0 / 3 |
| Phase 1 Schedule B: Pralatrexate 25 mg/m2, Romidepsin 12 mg/m2 | 2 / 6 | 6 / 6 | 0 / 6 |
| Phase 2: Pralatrexate 25 mg/m2, Romidepsin 12 mg/m2 | 4 / 18 | 13 / 18 | 1 / 18 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 1
- num At Risk
- 18
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 1
- num At Risk
- 18
- term
- Appendicitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Colonic hemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Erythema multiforme
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 2
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Lung infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 1
- num At Risk
- 18
- term
- Lymph gland infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Mucositis oral
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Neoplasms benign, malignant and unspecified
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Non-cardiac chest pain
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 2
- num At Risk
- 18
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Allergic rhinitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 2
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 2
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 3
- num At Risk
- 18
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 3
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 2
- num At Risk
- 18
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 1
- num At Risk
- 18
- term
- Anxiety
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 1
- num At Risk
- 18
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Back pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Bloating
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Blood bilirubin increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 1
- num At Risk
- 18
- term
- Blurred vision
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- C. difficle infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 1
- num At Risk
- 18
- term
- Chills
Complete source fields
- event Groups
- deaths Num Affected
- 0
- deaths Num At Risk
- 3
- description
- Cohort 1, Dose Level -1 Subjects will be administered through IV: Pralatrexate10 mg/m2 on days 1 and 8 of each 21 day cycle. Romidepsin 12mg/m2 on days 1 and 8 of each 21 daycycle
- id
- EG000
- other Num Affected
- 3
- other Num At Risk
- 3
- serious Num Affected
- 0
- serious Num At Risk
- 3
- title
- Pralatrexate 10 mg/m2, Romidepsin 12mg/m2
- deaths Num Affected
- 1
- deaths Num At Risk
- 3
- description
- Cohort 2A, Dose Level 1 Subjects will be administered through IV: Pralatrexate 15 mg/m2 on days 1 and 8 of each 21 day cycle. Romidepsin 12 mg/m2 on days 1 and 8 of each 21 day cycle.
- id
- EG001
- other Num Affected
- 3
- other Num At Risk
- 3
- serious Num Affected
- 1
- serious Num At Risk
- 3
- title
- Phase 1 Schedule A: Pralatrexate 15 mg/m2, Romidepsin 12 mg/m2
- deaths Num Affected
- 0
- deaths Num At Risk
- 3
- description
- Cohort 2B, Dose Level 1 Subjects will be administered through IV: Pralatrexate 15 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 12 mg/m2 on days 1 and 15 of each 28 day cycle.
- id
- EG002
- other Num Affected
- 3
- other Num At Risk
- 3
- serious Num Affected
- 0
- serious Num At Risk
- 3
- title
- Phase 1 Schedule B: Pralatrexate 15 mg/m2, Romidepsin 12 mg/m2
- deaths Num Affected
- 0
- deaths Num At Risk
- 3
- description
- Cohort 3A, Dose Level 2 Subjects will be administered through IV: Pralatrexate 15 mg/m2 on days 1 and 8 of each 21 day cycle. Romidepsin 14 mg/m2 on days 1 and 8 of each 21 day cycle.
- id
- EG003
- other Num Affected
- 3
- other Num At Risk
- 3
- serious Num Affected
- 1
- serious Num At Risk
- 3
- title
- Phase 1 Schedule A: Pralatrexate 15 mg/m2, Romidepsin 14 mg/m2
- deaths Num Affected
- 2
- deaths Num At Risk
- 3
- description
- Cohort 3B, Dose Level 2 Subjects will be administered through IV: Pralatrexate 15 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 14 mg/m2 on days 1 and 15 of each 28 day cycle.
- id
- EG004
- other Num Affected
- 3
- other Num At Risk
- 3
- serious Num Affected
- 1
- serious Num At Risk
- 3
- title
- Phase 1 Schedule B: Pralatrexate 15 mg/m2, Romidepsin 14 mg/m2
- deaths Num Affected
- 0
- deaths Num At Risk
- 5
- description
- Cohort 4A, Dose Level 3 Subjects will be administered through IV: Pralatrexate 20 mg/m2 on days 1 and 8 of each 21 day cycle. Romidepsin 12 mg/m2 on days 1 and 8 of each 21 day cycle.
- id
- EG005
- other Num Affected
- 5
- other Num At Risk
- 5
- serious Num Affected
- 2
- serious Num At Risk
- 5
- title
- Phase 1 Schedule A: Pralatrexate 20 mg/m2, Romidepsin 12 mg/m2
- deaths Num Affected
- 0
- deaths Num At Risk
- 3
- description
- Cohort 4B, Dose Level 3 Subjects will be administered through IV: Pralatrexate 20 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 12 mg/m2 on days 1 and 15 of each 28 day cycle.
- id
- EG006
- other Num Affected
- 3
- other Num At Risk
- 3
- serious Num Affected
- 1
- serious Num At Risk
- 3
- title
- Phase 1 Schedule B: Pralatrexate 20 mg/m2, Romidepsin 12 mg/m2
- deaths Num Affected
- 0
- deaths Num At Risk
- 6
- description
- Cohort 5B, Dose Level 4 Subjects will be administered through IV: Pralatrexate 25 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 12 mg/m2 on days 1 and 15 of each 28 day cycle.
- id
- EG007
- other Num Affected
- 6
- other Num At Risk
- 6
- serious Num Affected
- 2
- serious Num At Risk
- 6
- title
- Phase 1 Schedule B: Pralatrexate 25 mg/m2, Romidepsin 12 mg/m2
- deaths Num Affected
- 1
- deaths Num At Risk
- 18
- description
- Subjects will be administered through IV: Pralatrexate 25 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 12 mg/m2 on days 1 and 15 of each 28 day cycle.
- id
- EG008
- other Num Affected
- 13
- other Num At Risk
- 18
- serious Num Affected
- 4
- serious Num At Risk
- 18
- title
- Phase 2: Pralatrexate 25 mg/m2, Romidepsin 12 mg/m2
- frequency Threshold
- 0
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 2
- num At Risk
- 18
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Allergic rhinitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 2
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 2
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 3
- num At Risk
- 18
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 3
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 2
- num At Risk
- 18
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 1
- num At Risk
- 18
- term
- Anxiety
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 1
- num At Risk
- 18
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Back pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Bloating
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Blood bilirubin increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 1
- num At Risk
- 18
- term
- Blurred vision
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- C. difficle infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 1
- num At Risk
- 18
- term
- Chills
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 1
- num At Risk
- 18
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 1
- num At Risk
- 18
- term
- Appendicitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Colonic hemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Erythema multiforme
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 2
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Lung infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 1
- num At Risk
- 18
- term
- Lymph gland infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Mucositis oral
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Neoplasms benign, malignant and unspecified
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG007
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG008
- num Affected
- 0
- num At Risk
- 18
- term
- Non-cardiac chest pain
- time Frame
- up to 3 years
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice
Triangle