TriangleNCT02631070 · OUTCOME
Duration of Red Blood Cell Transfusion Independence (RBC-TI) - Week 1 Through Week 48
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From start of study treatment to 16 weeks after last dose, up to approximately 93 weeks
What was measured
Duration of RBC-TI was defined as the longest duration of response for participants who achieved RBC-TI of ≥ 8 weeks during the treatment period Week 1 through Week 48. Participants who maintained RBC-TI through the end of the treatment period were censored at the date of IP discontinuation or death, whichever occurred first. Median was estimated from unstratified Kaplan Meier method.
Analysis population: All treated participants who achieved RBC-TI ≥ 8 weeks during Week 1 through Week 48 of study treatment
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 | 69 |
| Placebo | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Luspatercept | 30.6 | Not reported | 20.6 | 50.9 | Not reported |
| Placebo | 18.6 | Not reported | 10.9 | NA | Upper limit could not be estimated due to insufficient number of events |
Source statistical analyses
- ci Lower Limit
- 0.362
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.699
- estimate Comment
- HR is from the Cox proportional hazards model
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.5121
- param Type
- Hazard Ratio (HR)
- param Value
- 0.784
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.362
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.699
- estimate Comment
- HR is from the Cox proportional hazards model
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.5121
- param Type
- Hazard Ratio (HR)
- param Value
- 0.784
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 20.6
- upper Limit
- 50.9
- value
- 30.6
- comment
- Upper limit could not be estimated due to insufficient number of events
- group Id
- OG001
- lower Limit
- 10.9
- upper Limit
- NA
- value
- 18.6
- denoms
- counts
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- Duration of RBC-TI was defined as the longest duration of response for participants who achieved RBC-TI of ≥ 8 weeks during the treatment period Week 1 through Week 48. Participants who maintained RBC-TI through the end of the treatment period were censored at the date of IP discontinuation or death, whichever occurred first. Median was estimated from unstratified Kaplan Meier method.
- 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 who achieved RBC-TI ≥ 8 weeks during Week 1 through Week 48 of study treatment
- reporting Status
- POSTED
- time Frame
- From start of study treatment to 16 weeks after last dose, up to approximately 93 weeks
- title
- Duration of Red Blood Cell Transfusion Independence (RBC-TI) - Week 1 Through Week 48
- type
- SECONDARY
- unit Of Measure
- Weeks
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice