TriangleNCT00103610 · OUTCOME
Median Number of Days of Apheresis Required to Achieve >=5*10^6 CD34+ Cells/kg
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 Day 8
What was measured
The Kaplan Meier estimate of median number of days (number of days at which 50% of participants reached the threshold, accounting for censored values) in each treatment arm to collect the target number of cells (≥5\*10\^6 CD34+ cells/kg) for transplantation. Central laboratory values were used.
Analysis population: Intent-to-Treat Population.
Groups in this outcome
G-CSF + 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 + Plerixafor | 147 |
| G-CSF Plus Placebo | 142 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| G-CSF + Plerixafor | 3.0 | Not reported | 1.0 | NA | Not enough participants reached the threshold to support estimating the upper range. |
| G-CSF Plus Placebo | NA | Not reported | NA | NA | Not enough participants reached the threshold to estimate the values. |
Complete source fields
- classes
- categories
- measurements
- comment
- Not enough participants reached the threshold to support estimating the upper range.
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- NA
- value
- 3.0
- comment
- Not enough participants reached the threshold to estimate the values.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 147
- group Id
- OG001
- value
- 142
- units
- Participants
- description
- The Kaplan Meier estimate of median number of days (number of days at which 50% of participants reached the threshold, accounting for censored values) in each treatment arm to collect the target number of cells (≥5\*10\^6 CD34+ cells/kg) for transplantation. Central laboratory values were used.
- 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 + 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
- Intent-to-Treat Population.
- reporting Status
- POSTED
- time Frame
- up to Day 8
- title
- Median Number of Days of Apheresis Required to Achieve >=5*10^6 CD34+ Cells/kg
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice