TriangleNCT03682536 · OUTCOME
Percentage of Participants Achieving Red Blood Cell Transfusion Independence (RBC-TI) for ≥ 56 Days (8 Weeks)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percent of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Week 1 through Week 24
What was measured
Defined as percentage of participants achieving RBC-TI for \>= 56 days during any consecutive 56-day period from Week 1 through Week 24.
Analysis population: ITT Population - all randomized participants regardless of whether or not the participant received treatment.
Groups in this outcome
Luspatercept
Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.
Epoetin Alfa
Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).
| Group | Source count |
|---|---|
| Luspatercept | 182 |
| Epoetin Alfa | 181 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Luspatercept | 79.1 | Not reported | 72.5 | 84.8 | Not reported |
| Epoetin Alfa | 64.6 | Not reported | 57.2 | 71.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.8
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0007
- param Type
- Odds Ratio (OR)
- param Value
- 2.3
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 1.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.8
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0007
- param Type
- Odds Ratio (OR)
- param Value
- 2.3
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 72.5
- upper Limit
- 84.8
- value
- 79.1
- group Id
- OG001
- lower Limit
- 57.2
- upper Limit
- 71.6
- value
- 64.6
- denoms
- counts
- group Id
- OG000
- value
- 182
- group Id
- OG001
- value
- 181
- units
- Participants
- description
- Defined as percentage of participants achieving RBC-TI for \>= 56 days during any consecutive 56-day period from Week 1 through Week 24.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.
- id
- OG000
- title
- Luspatercept
- description
- Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).
- id
- OG001
- title
- Epoetin Alfa
- param Type
- NUMBER
- population Description
- ITT Population - all randomized participants regardless of whether or not the participant received treatment.
- reporting Status
- POSTED
- time Frame
- Week 1 through Week 24
- title
- Percentage of Participants Achieving Red Blood Cell Transfusion Independence (RBC-TI) for ≥ 56 Days (8 Weeks)
- type
- SECONDARY
- unit Of Measure
- Percent of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice