NCT00357500 · 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
- 27 weeks
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| 5-drug Metronomic Antiangiogenic Regimen | 74 / 97 | 81 / 97 | Not reported / Not reported |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- DE140
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Death - disease progression NOS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 97
- term
- Hemoglobin
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Hematologic-other
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 97
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Hearing w/w-o audiogr in monitor prg
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 97
- term
- Diarrhea w/o prior colostomy
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 97
- term
- Muco/stomatitis by exam, oral cavity
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Muco/stomatitis (symptom) oral cavity
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Abdomen, pain
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Myelodysplasia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 52
- num At Risk
- 97
- term
- Hemoglobin
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Palpitations
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Sinus tachycardia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Cushingnoid appearance
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Neuropathy CN II vision
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Cataract
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Keratitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Ocular-other
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 97
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 97
- term
- Diarrhea w/o prior colostomy
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 97
- term
- Distention/bloating, abdominal
Complete source fields
- event Groups
- description
- Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: \< 20 kg at 100 mg; 20-50 kg at 200 mg; \> 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
- id
- EG000
- other Num Affected
- 81
- other Num At Risk
- 97
- serious Num Affected
- 74
- serious Num At Risk
- 97
- title
- 5-drug Metronomic Antiangiogenic Regimen
- frequency Threshold
- 0
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Myelodysplasia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 52
- num At Risk
- 97
- term
- Hemoglobin
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Palpitations
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Sinus tachycardia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Cushingnoid appearance
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Neuropathy CN II vision
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Cataract
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Keratitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Ocular-other
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 97
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 97
- term
- Diarrhea w/o prior colostomy
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 97
- term
- Distention/bloating, abdominal
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- DE140
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Death - disease progression NOS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 97
- term
- Hemoglobin
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Hematologic-other
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 97
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Hearing w/w-o audiogr in monitor prg
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 97
- term
- Diarrhea w/o prior colostomy
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 97
- term
- Muco/stomatitis by exam, oral cavity
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Muco/stomatitis (symptom) oral cavity
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 97
- term
- Abdomen, pain
- time Frame
- 27 weeks
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