NCT00335556 · 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
- Not reported
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Surgery | 2 / 66 | 0 / 66 | Not reported / Not reported |
| UH-1 | 19 / 98 | 81 / 98 | Not reported / Not reported |
| Window/UH-1 | 3 / 7 | 5 / 7 | Not reported / Not reported |
| UH-2 | 0 / 10 | 9 / 10 | Not reported / Not reported |
| Regimen I | 3 / 78 | 7 / 78 | Not reported / Not reported |
| Regimen DD-4A | 1 / 30 | 1 / 30 | Not reported / Not reported |
Serious adverse events
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 98
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 10300-Abdominal pain
- organ System
- Renal and urinary disorders
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 98
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 11100-Acute kidney injury
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 98
- num Events
- 2
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 11300-Adult respiratory distress syndrome
- organ System
- Investigations
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 98
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 11600-Alanine aminotransferase increased
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 98
- num Events
- 2
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 14900-Ascites
- organ System
- Investigations
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 98
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 15000-Aspartate aminotransferase increased
- organ System
- Investigations
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 98
- num Events
- 2
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 17400-Blood bilirubin increased
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 98
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 19200-Bronchopulmonary hemorrhage
- organ System
- Cardiac disorders
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 98
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 20000-Cardiac arrest
- organ System
- Cardiac disorders
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 98
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 20100-Cardiac disorders - Other specify
- organ System
- Investigations
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 98
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 24100-Creatinine increased
- organ System
- General disorders
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 98
- num Events
- 5
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 7
- num Events
- 2
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 78
- num Events
- 2
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 30
- num Events
- 1
- term
- 24600-Death NOS
Other reported adverse events
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 98
- num Events
- 0
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 7
- num Events
- 2
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 10100-Abdominal distension
- organ System
- Infections and infestations
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 98
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 10200-Abdominal infection
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 98
- num Events
- 6
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 10300-Abdominal pain
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 98
- num Events
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 10700-Acidosis
- organ System
- Renal and urinary disorders
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 98
- num Events
- 2
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 11100-Acute kidney injury
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 98
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 11300-Adult respiratory distress syndrome
- organ System
- Psychiatric disorders
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 98
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 11400-Agitation
- organ System
- Investigations
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 98
- num Events
- 10
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 11600-Alanine aminotransferase increased
- organ System
- Immune system disorders
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 98
- num Events
- 2
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 13100-Anaphylaxis
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 98
- num Events
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 13200-Anemia
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 20
- num At Risk
- 98
- num Events
- 22
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 7
- num Events
- 3
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 10
- num Events
- 2
- group Id
- EG004
- num Affected
- 3
- num At Risk
- 78
- num Events
- 4
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 13500-Anorexia
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 98
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 14100-Apnea
Complete source fields
- event Groups
- description
- Surgery Only
- id
- EG000
- other Num Affected
- 0
- other Num At Risk
- 66
- serious Num Affected
- 2
- serious Num At Risk
- 66
- title
- Surgery
- description
- Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT
- id
- EG001
- other Num Affected
- 81
- other Num At Risk
- 98
- serious Num Affected
- 19
- serious Num At Risk
- 98
- title
- UH-1
- description
- Window therapy of vincristine/irinotecan; Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT"
- id
- EG002
- other Num Affected
- 5
- other Num At Risk
- 7
- serious Num Affected
- 3
- serious Num At Risk
- 7
- title
- Window/UH-1
- description
- Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT
- id
- EG003
- other Num Affected
- 9
- other Num At Risk
- 10
- serious Num Affected
- 0
- serious Num At Risk
- 10
- title
- UH-2
- description
- Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT
- id
- EG004
- other Num Affected
- 7
- other Num At Risk
- 78
- serious Num Affected
- 3
- serious Num At Risk
- 78
- title
- Regimen I
- description
- Vincristine/dactinomycin/doxorubicin x25 weeks; XRT"
- id
- EG005
- other Num Affected
- 1
- other Num At Risk
- 30
- serious Num Affected
- 1
- serious Num At Risk
- 30
- title
- Regimen DD-4A
- frequency Threshold
- 0
- other Events
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 98
- num Events
- 0
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 7
- num Events
- 2
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 10100-Abdominal distension
- organ System
- Infections and infestations
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 98
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 78
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- term
- 10200-Abdominal infection
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCv4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- num Events
- 0
- group Id
- EG001
- num Affected
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