TriangleNCT00943800 · OUTCOME
Percentage of Participants With Neutrophil Engraftment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Transplant (Day 0) through Day +28
What was measured
Cumulative incidence of graft failure (neutrophil) by day 28 was reported. Patients who did not have neutrophil engraftment before death was considered as a competing risk. Failure to engraft was defined as lack of evidence of hematopoietic recovery (ANC \<500/mm3 and platelet count \< 20,000/mm3) by day +35, confirmed by a biopsy revealing a marrow cellularity \< 5%. Graft failure was also defined as initial myeloid engraftment by day +35, documented to be of donor origin, followed by a drop in the ANC to \< 500/mm3 for more than three days, independent of any myelosuppressive drugs, severe GVHD, CMV, or other infection.
Groups in this outcome
Treatment Group
Although the protocol initially had different disease intensities, ultimately, moved to one regimen for all patients. Subjects received 30mg/m\^2 of Fludarabine from Day-7 until Day-3, 140mg/m\^2 of Melphalan on Day-2, and 1.5mg/kg of Rabbit antithymocyte globulin at Day-7,-5,-3 and -1."
| Group | Source count |
|---|---|
| Treatment Group | 87 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Group | 85.1 | Not reported | 75.4 | 91.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 75.4
- upper Limit
- 91.1
- value
- 85.1
- denoms
- counts
- group Id
- OG000
- value
- 87
- units
- Participants
- description
- Cumulative incidence of graft failure (neutrophil) by day 28 was reported. Patients who did not have neutrophil engraftment before death was considered as a competing risk. Failure to engraft was defined as lack of evidence of hematopoietic recovery (ANC \<500/mm3 and platelet count \< 20,000/mm3) by day +35, confirmed by a biopsy revealing a marrow cellularity \< 5%. Graft failure was also defined as initial myeloid engraftment by day +35, documented to be of donor origin, followed by a drop in the ANC to \< 500/mm3 for more than three days, independent of any myelosuppressive drugs, severe GVHD, CMV, or other infection.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Although the protocol initially had different disease intensities, ultimately, moved to one regimen for all patients. Subjects received 30mg/m\^2 of Fludarabine from Day-7 until Day-3, 140mg/m\^2 of Melphalan on Day-2, and 1.5mg/kg of Rabbit antithymocyte globulin at Day-7,-5,-3 and -1."
- id
- OG000
- title
- Treatment Group
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Transplant (Day 0) through Day +28
- title
- Percentage of Participants With Neutrophil Engraftment
- type
- PRIMARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice