TriangleNCT00103610 · OUTCOME
Graft Durability at 12 Months Post Transplantation
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- Not reported
- Time frame
- approximately Month 13
What was measured
The proportion of participants maintaining a durable graft 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count \>50000/µL without transfusion for at least 2 weeks, (2) hemoglobin \>=10g/dL for at least 1 month, (3) and absolute neutrophil count \>1000/µL for at least 1 week.
Analysis population: Participants who received a stem cell transplant and were evaluable at 12 months post-transplant
Groups in this outcome
G-CSF Plus Plerixafor
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
G-CSF Plus Placebo
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
| Group | Source count |
|---|---|
| G-CSF Plus Plerixafor | 112 |
| G-CSF Plus Placebo | 65 |
Reported measurements
Proportion of participants with a durable graft
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| G-CSF Plus Plerixafor | 0.982 | Not reported | Not reported | Not reported | Not reported |
| G-CSF Plus Placebo | 1.0 | Not reported | Not reported | Not reported | Not reported |
Proportion of participants without a durable graft
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| G-CSF Plus Plerixafor | 0.018 | Not reported | Not reported | Not reported | Not reported |
| G-CSF Plus Placebo | 0.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.982
- group Id
- OG001
- value
- 1.0
- title
- Proportion of participants with a durable graft
- categories
- measurements
- group Id
- OG000
- value
- 0.018
- group Id
- OG001
- value
- 0.0
- title
- Proportion of participants without a durable graft
- denoms
- counts
- group Id
- OG000
- value
- 112
- group Id
- OG001
- value
- 65
- units
- Participants
- description
- The proportion of participants maintaining a durable graft 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count \>50000/µL without transfusion for at least 2 weeks, (2) hemoglobin \>=10g/dL for at least 1 month, (3) and absolute neutrophil count \>1000/µL for at least 1 week.
- groups
- description
- Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
- id
- OG000
- title
- G-CSF Plus Plerixafor
- description
- Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
- id
- OG001
- title
- G-CSF Plus Placebo
- param Type
- NUMBER
- population Description
- Participants who received a stem cell transplant and were evaluable at 12 months post-transplant
- reporting Status
- POSTED
- time Frame
- approximately Month 13
- title
- Graft Durability at 12 Months Post Transplantation
- type
- SECONDARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice