TriangleNCT00103610 · OUTCOME
Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- Up to Month 13
What was measured
The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as PMN counts ≥ 0.5\*10\^9/L for 3 consecutive days or ≥ 1.0\*10\^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.
Analysis population: Participants who received a stem cell 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 | 135 |
| G-CSF Plus Placebo | 82 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| G-CSF Plus Plerixafor | 10.0 | Not reported | 10.0 | 11.0 | Not reported |
| G-CSF Plus Placebo | 10.0 | Not reported | 10.0 | 11.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.0
- upper Limit
- 11.0
- value
- 10.0
- group Id
- OG001
- lower Limit
- 10.0
- upper Limit
- 11.0
- value
- 10.0
- denoms
- counts
- group Id
- OG000
- value
- 135
- group Id
- OG001
- value
- 82
- units
- Participants
- description
- The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as PMN counts ≥ 0.5\*10\^9/L for 3 consecutive days or ≥ 1.0\*10\^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.
- dispersion Type
- Inter-Quartile Range
- 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
- MEDIAN
- population Description
- Participants who received a stem cell transplant.
- reporting Status
- POSTED
- time Frame
- Up to Month 13
- title
- Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice