NCT00544115 · OUTCOME
Neutrophil Engraftment - The Days Till ANC Recovery
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 180 days post transplant
What was measured
The primary engraftment endpoint, neutrophil engraftment, is defined as the first of three consecutive days on which the absolute neutrophil count is \> 500/µL. The duration and extent of neutrophil engraftment is the time from transplant to neutrophil engraftment.
Analysis population: Some patients had engraftment failure and some had missing data. Therefore, the overall number of participants analyzed in each regimen is less than the overall number in the Participant Flow module.
Groups in this outcome
Regimen I
Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1. cyclophosphamide cyclosporine methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation
Regimen II
Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2. busulfan cyclophosphamide cyclosporine methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
Regimen III
Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3. cyclosporine etoposide methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation
Regimen IV
Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2. cyclosporine fludarabine phosphate melphalan methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
Regimen V
Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0. cyclosporine fludarabine phosphate methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation
Regimen VI
Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2. busulfan cyclosporine fludarabine phosphate methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
| Group | Source count |
|---|---|
| Regimen I | 42 |
| Regimen II | 13 |
| Regimen III | 113 |
| Regimen IV | 3 |
| Regimen V | 36 |
| Regimen VI | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Regimen I | 17 | Not reported | 11 | 39 | Not reported |
| Regimen II | 16 | Not reported | 13 | 21 | Not reported |
| Regimen III | 15 | Not reported | 8 | 36 | Not reported |
| Regimen IV | 14 | Not reported | 14 | 17 | Not reported |
| Regimen V | 18 | Not reported | 11 | 28 | Not reported |
| Regimen VI | 16 | Not reported | 16 | 16 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11
- upper Limit
- 39
- value
- 17
- group Id
- OG001
- lower Limit
- 13
- upper Limit
- 21
- value
- 16
- group Id
- OG002
- lower Limit
- 8
- upper Limit
- 36
- value
- 15
- group Id
- OG003
- lower Limit
- 14
- upper Limit
- 17
- value
- 14
- group Id
- OG004
- lower Limit
- 11
- upper Limit
- 28
- value
- 18
- group Id
- OG005
- lower Limit
- 16
- upper Limit
- 16
- value
- 16
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 113
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 36
- group Id
- OG005
- value
- 1
- units
- Participants
- description
- The primary engraftment endpoint, neutrophil engraftment, is defined as the first of three consecutive days on which the absolute neutrophil count is \> 500/µL. The duration and extent of neutrophil engraftment is the time from transplant to neutrophil engraftment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1. cyclophosphamide cyclosporine methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation
- id
- OG000
- title
- Regimen I
- description
- Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2. busulfan cyclophosphamide cyclosporine methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
- id
- OG001
- title
- Regimen II
- description
- Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3. cyclosporine etoposide methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation
- id
- OG002
- title
- Regimen III
- description
- Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2. cyclosporine fludarabine phosphate melphalan methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
- id
- OG003
- title
- Regimen IV
- description
- Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0. cyclosporine fludarabine phosphate methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation
- id
- OG004
- title
- Regimen V
- description
- Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2. busulfan cyclosporine fludarabine phosphate methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
- id
- OG005
- title
- Regimen VI
- param Type
- MEDIAN
- population Description
- Some patients had engraftment failure and some had missing data. Therefore, the overall number of participants analyzed in each regimen is less than the overall number in the Participant Flow module.
- reporting Status
- POSTED
- time Frame
- Up to 180 days post transplant
- title
- Neutrophil Engraftment - The Days Till ANC Recovery
- type
- PRIMARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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