TriangleNCT03682536 · OUTCOME
Percentage of Participants Achieving Red Blood Cell Transfusion Independence (RBC-TI) for a Consecutive 24-week Period
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 48
What was measured
Defined as percentage of participants achieving RBC-TI for \>= 168 days during any consecutive 168-day period from Week 1 through Week 48.
Analysis population: ITT Population (all randomized participants regardless of whether or not the participant received treatment) whose first dose date is at least 337 days from the cutoff date or discontinued early are included in this analysis.
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 | 163 |
| Epoetin Alfa | 167 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Luspatercept | 60.7 | Not reported | 52.8 | 68.3 | Not reported |
| Epoetin Alfa | 39.5 | Not reported | 32.1 | 47.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.3
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <.0001
- param Type
- Odds Ratio (OR)
- param Value
- 2.6
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 1.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.3
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <.0001
- param Type
- Odds Ratio (OR)
- param Value
- 2.6
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 52.8
- upper Limit
- 68.3
- value
- 60.7
- group Id
- OG001
- lower Limit
- 32.1
- upper Limit
- 47.4
- value
- 39.5
- denoms
- counts
- group Id
- OG000
- value
- 163
- group Id
- OG001
- value
- 167
- units
- Participants
- description
- Defined as percentage of participants achieving RBC-TI for \>= 168 days during any consecutive 168-day period from Week 1 through Week 48.
- 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) whose first dose date is at least 337 days from the cutoff date or discontinued early are included in this analysis.
- reporting Status
- POSTED
- time Frame
- Week 1 through Week 48
- title
- Percentage of Participants Achieving Red Blood Cell Transfusion Independence (RBC-TI) for a Consecutive 24-week Period
- type
- SECONDARY
- unit Of Measure
- Percent of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice