NCT00544115 · OUTCOME
Two-year Overall Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of survival probability
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 2 years post transplant
What was measured
Overall survival (OS) was measured from peripheral stem cell infusion to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. Participants were followed up to 2 years after transplant and Kaplan-Meier survival analysis was used to generate the two-year Overall Survival estimate presented.
Analysis population: 1 subject in Regimen II did not have transplant.
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 | 62 |
| Regimen II | 16 |
| Regimen III | 130 |
| Regimen IV | 4 |
| Regimen V | 40 |
| Regimen VI | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Regimen I | 58 | Not reported | 45 | 69 | Not reported |
| Regimen II | 50 | Not reported | 25 | 71 | Not reported |
| Regimen III | 54 | Not reported | 45 | 62 | Not reported |
| Regimen IV | 50 | Not reported | 6 | 84 | Not reported |
| Regimen V | 38 | Not reported | 23 | 52 | Not reported |
| Regimen VI | 50 | Not reported | 0.1 | 91 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 45
- upper Limit
- 69
- value
- 58
- group Id
- OG001
- lower Limit
- 25
- upper Limit
- 71
- value
- 50
- group Id
- OG002
- lower Limit
- 45
- upper Limit
- 62
- value
- 54
- group Id
- OG003
- lower Limit
- 6
- upper Limit
- 84
- value
- 50
- group Id
- OG004
- lower Limit
- 23
- upper Limit
- 52
- value
- 38
- group Id
- OG005
- lower Limit
- 0.1
- upper Limit
- 91
- value
- 50
- denoms
- counts
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 130
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 40
- group Id
- OG005
- value
- 2
- units
- Participants
- description
- Overall survival (OS) was measured from peripheral stem cell infusion to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. Participants were followed up to 2 years after transplant and Kaplan-Meier survival analysis was used to generate the two-year Overall Survival estimate presented.
- 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
- NUMBER
- population Description
- 1 subject in Regimen II did not have transplant.
- reporting Status
- POSTED
- time Frame
- Up to 2 years post transplant
- title
- Two-year Overall Survival
- type
- SECONDARY
- unit Of Measure
- percentage of survival probability
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Preserved source evidence · Not medical advice
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