TriangleNCT00448357 · OUTCOME
Three-year Relapse-free Survival (RFS) Rate at the Maximum Tolerated Dose Identified During Phase I of the Trial (Target AUC 6912)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Three years post-transplant
What was measured
Relapse is defined as new or increased sites of disease or positive one marrow after a complete response (CR). The RFS was calculated as the percentage of patients who were alive and without relapse at 3 years
Analysis population: Because AUC levels varied between the groups and the goal was to identify an actual achieved AUC-based dose, additional outcome analyses were undertaken by dividing patients into thirds according to the actual AUCs delivered rather than the original planned AUCs.
Groups in this outcome
Low Busulfan AUC Tertile
Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 5078 (full range 3933-5615) microM/min
Intermediate Busulfan AUC Tertile
Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 6372 (full range 5639-6965) microM/min
High Busulfan AUC Tertile
Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 7605 (full range 7054-8863) microM/min
| Group | Source count |
|---|---|
| Low Busulfan AUC Tertile | 18 |
| Intermediate Busulfan AUC Tertile | 18 |
| High Busulfan AUC Tertile | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low Busulfan AUC Tertile | 22 | Not reported | Not reported | Not reported | Not reported |
| Intermediate Busulfan AUC Tertile | 39 | Not reported | Not reported | Not reported | Not reported |
| High Busulfan AUC Tertile | 43 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 39
- group Id
- OG002
- value
- 43
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 18
- units
- Participants
- description
- Relapse is defined as new or increased sites of disease or positive one marrow after a complete response (CR). The RFS was calculated as the percentage of patients who were alive and without relapse at 3 years
- groups
- description
- Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 5078 (full range 3933-5615) microM/min
- id
- OG000
- title
- Low Busulfan AUC Tertile
- description
- Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 6372 (full range 5639-6965) microM/min
- id
- OG001
- title
- Intermediate Busulfan AUC Tertile
- description
- Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 7605 (full range 7054-8863) microM/min
- id
- OG002
- title
- High Busulfan AUC Tertile
- param Type
- NUMBER
- population Description
- Because AUC levels varied between the groups and the goal was to identify an actual achieved AUC-based dose, additional outcome analyses were undertaken by dividing patients into thirds according to the actual AUCs delivered rather than the original planned AUCs.
- reporting Status
- POSTED
- time Frame
- Three years post-transplant
- title
- Three-year Relapse-free Survival (RFS) Rate at the Maximum Tolerated Dose Identified During Phase I of the Trial (Target AUC 6912)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice