NCT00635024 · 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 |
|---|---|---|---|
| Anti-thymocyte Globulin/Melphalan | 0 / 1 | 1 / 1 | Not reported / Not reported |
Serious adverse events
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- term
- Hypersensitivity
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- term
- Opportunistic Infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- term
- Neutrophil Count Decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 2
- term
- Platelet Count Decreased
Complete source fields
- event Groups
- description
- Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m\^2)
- id
- EG000
- other Num Affected
- 1
- other Num At Risk
- 1
- serious Num Affected
- 0
- serious Num At Risk
- 1
- title
- Anti-thymocyte Globulin/Melphalan
- frequency Threshold
- 0
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- term
- Hypersensitivity
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- term
- Opportunistic Infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- term
- Neutrophil Count Decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 2
- term
- Platelet Count Decreased
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Preserved source evidence · Not medical advice
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