TriangleNCT00434161 · OUTCOME
Time Death or Disease Progression
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- During long-term follow up phase (maximum of 10 years)
What was measured
For the analysis of time to disease progression, competing risks time-to-event analysis was used, since a subject destined to develop disease progression could die from unrelated causes before the disease progression event takes place. Kaplan-Meier survival estimates, with death due to other causes than progression considered as a competing risk, were provided: event rate at 3 month intervals, with 95% confidence interval, the number of subjects at risk at the beginning of the time period, and the number of events of interest.
Analysis population: A total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47.
Groups in this outcome
Palifermin (Palifermin Before Only and, Before and After)
Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
Placebo
Subjects to receive matched placebo before- and after-high dose chemotherapy
| Group | Source count |
|---|---|
| Palifermin (Palifermin Before Only and, Before and After) | 220 |
| Placebo | 57 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palifermin (Palifermin Before Only and, Before and After) | 15.1 | Not reported | 8.4 | 24.0 | Not reported |
| Placebo | 18.3 | Not reported | 11.9 | 27.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.58
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.23
- group Description
- All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.372
- param Type
- Hazard Ratio, log
- param Value
- 0.84
- statistical Method
- Log Rank
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 0.58
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.23
- group Description
- All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.372
- param Type
- Hazard Ratio, log
- param Value
- 0.84
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.4
- upper Limit
- 24.0
- value
- 15.1
- group Id
- OG001
- lower Limit
- 11.9
- upper Limit
- 27.5
- value
- 18.3
- denoms
- counts
- group Id
- OG000
- value
- 220
- group Id
- OG001
- value
- 57
- units
- Participants
- description
- For the analysis of time to disease progression, competing risks time-to-event analysis was used, since a subject destined to develop disease progression could die from unrelated causes before the disease progression event takes place. Kaplan-Meier survival estimates, with death due to other causes than progression considered as a competing risk, were provided: event rate at 3 month intervals, with 95% confidence interval, the number of subjects at risk at the beginning of the time period, and the number of events of interest.
- dispersion Type
- Inter-Quartile Range
- groups
- description
- Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
- id
- OG000
- title
- Palifermin (Palifermin Before Only and, Before and After)
- description
- Subjects to receive matched placebo before- and after-high dose chemotherapy
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- A total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47.
- reporting Status
- POSTED
- time Frame
- During long-term follow up phase (maximum of 10 years)
- title
- Time Death or Disease Progression
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice