TriangleNCT02631070 · OUTCOME
Overall Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to study completion (up to approximately 57 months)
What was measured
Overall Survival was defined as the time from the date of study drug randomization to death due to any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for those who discontinued from the study or were lost to follow-up.
Analysis population: All treated participants
Groups in this outcome
Luspatercept
Luspatercept 1.0 mg/Kg SC on Day 1 of each 21-day treatment cycle
Placebo
Placebo (Volume equivalent to experimental arm) SC on Day 1 of each 21-day treatment cycle
| Group | Source count |
|---|---|
| Luspatercept | 153 |
| Placebo | 76 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Luspatercept | 46.0 | Not reported | 42.0 | NA | Upper limit could not be estimated because of the insufficient number of events |
| Placebo | NA | Not reported | 43.1 | NA | Median and Upper limit could not be estimated because of the insufficient number of events |
Source statistical analyses
- ci Lower Limit
- 0.595
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.636
- estimate Comment
- HR is from the Cox proportional hazards model
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.9580
- param Type
- Hazard Ratio (HR)
- param Value
- 0.986
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.595
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.636
- estimate Comment
- HR is from the Cox proportional hazards model
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.9580
- param Type
- Hazard Ratio (HR)
- param Value
- 0.986
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Upper limit could not be estimated because of the insufficient number of events
- group Id
- OG000
- lower Limit
- 42.0
- upper Limit
- NA
- value
- 46.0
- comment
- Median and Upper limit could not be estimated because of the insufficient number of events
- group Id
- OG001
- lower Limit
- 43.1
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 153
- group Id
- OG001
- value
- 76
- units
- Participants
- description
- Overall Survival was defined as the time from the date of study drug randomization to death due to any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for those who discontinued from the study or were lost to follow-up.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Luspatercept 1.0 mg/Kg SC on Day 1 of each 21-day treatment cycle
- id
- OG000
- title
- Luspatercept
- description
- Placebo (Volume equivalent to experimental arm) SC on Day 1 of each 21-day treatment cycle
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- All treated participants
- reporting Status
- POSTED
- time Frame
- From randomization to study completion (up to approximately 57 months)
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice