NCT02722668 · 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
- 6 months
- Other-event reporting threshold
- 5%
Adverse event and/or serious adverse event recorded according to targeted reporting outlined in protocol. 1. Events requiring prompt reporting including, but not limited to unanticipated death of a locally enrolled subject(s); new or increased risk; any adverse event that require a change to the protocol or consent form or any protocol deviation that resulting in harm 2. graft failure by Day 42 post-transplant
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| No Anti-thymocyte Globulin (ATG) | 0 / 5 | 0 / 5 | 1 / 5 |
| Anti-thymocyte Globulin (ATG) | 0 / 10 | 0 / 10 | 2 / 10 |
Serious adverse events
Other reported adverse events
Complete source fields
- description
- Adverse event and/or serious adverse event recorded according to targeted reporting outlined in protocol. 1. Events requiring prompt reporting including, but not limited to unanticipated death of a locally enrolled subject(s); new or increased risk; any adverse event that require a change to the protocol or consent form or any protocol deviation that resulting in harm 2. graft failure by Day 42 post-transplant
- event Groups
- deaths Num Affected
- 1
- deaths Num At Risk
- 5
- description
- Hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycles of multi-agent chemotherapy within the 3 months previous to umbilical cord blood transplantation.
- id
- EG000
- other Num Affected
- 0
- other Num At Risk
- 5
- serious Num Affected
- 0
- serious Num At Risk
- 5
- title
- No Anti-thymocyte Globulin (ATG)
- deaths Num Affected
- 2
- deaths Num At Risk
- 10
- description
- Hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplantation, should receive Anti-thymocyte Globulin (ATG) as part of their conditioning regimen.
- id
- EG001
- other Num Affected
- 0
- other Num At Risk
- 10
- serious Num Affected
- 0
- serious Num At Risk
- 10
- title
- Anti-thymocyte Globulin (ATG)
- frequency Threshold
- 5
- time Frame
- 6 months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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