NCT00053989 · 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
- 100 days
- Other-event reporting threshold
- 0%
SAE=died before absolute neutrophil count recovery (DBE) or survived to day +28 without absolute neutrophil count recovery (FTE) AE=overall grade III-IV acute GVHD
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| All Patients | 3 / 41 | 6 / 41 | 8 / 41 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- died before absolute neutrophil count recovery (DBE) or survived to day +28 without absolute neutrophil count recovery (FTE)
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- Serious
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 41
- num Events
- 3
- term
- DBE/FTE
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- Other
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 41
- num Events
- 6
- term
- acute GVHD grade III-IV
Complete source fields
- description
- SAE=died before absolute neutrophil count recovery (DBE) or survived to day +28 without absolute neutrophil count recovery (FTE) AE=overall grade III-IV acute GVHD
- event Groups
- deaths Num Affected
- 8
- deaths Num At Risk
- 41
- description
- All patients enrolled on study
- id
- EG000
- other Num Affected
- 6
- other Num At Risk
- 41
- serious Num Affected
- 3
- serious Num At Risk
- 41
- title
- All Patients
- frequency Threshold
- 0
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- Other
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 41
- num Events
- 6
- term
- acute GVHD grade III-IV
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- died before absolute neutrophil count recovery (DBE) or survived to day +28 without absolute neutrophil count recovery (FTE)
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- Serious
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 41
- num Events
- 3
- term
- DBE/FTE
- time Frame
- 100 days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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