TriangleNCT03682536 · OUTCOME
Time to Hematologic Improvement - Erythroid Response (HI-E)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- Full Range
- Time frame
- Week 1 through Week 24
What was measured
Time from first dose to first onset of achieving modified HI-E. The modified HI-E criteria per the International Working Group (IWG) sustained over any consecutive 56-day period in Week 1-24: For participants with baseline red blood cell (RBC) transfusion burden of \>= 4 units/8 weeks, a reduction of at least 4 units RBC transfusion; for participants with baseline RBC transfusion burden of \< 4 units/8 weeks, mean increase of hemoglobin of at least 1.5 g/dL in the absence of transfusions.
Analysis population: ITT Population (all randomized participants regardless of whether or not the participant received treatment) who achieve HI-E response (Week 1-24)
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 | 135 |
| Epoetin Alfa | 96 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Luspatercept | 1.0 | Not reported | 1.0 | 113.0 | Not reported |
| Epoetin Alfa | 6.0 | Not reported | 1.0 | 108.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- 113.0
- value
- 1.0
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 108.0
- value
- 6.0
- denoms
- counts
- group Id
- OG000
- value
- 135
- group Id
- OG001
- value
- 96
- units
- Participants
- description
- Time from first dose to first onset of achieving modified HI-E. The modified HI-E criteria per the International Working Group (IWG) sustained over any consecutive 56-day period in Week 1-24: For participants with baseline red blood cell (RBC) transfusion burden of \>= 4 units/8 weeks, a reduction of at least 4 units RBC transfusion; for participants with baseline RBC transfusion burden of \< 4 units/8 weeks, mean increase of hemoglobin of at least 1.5 g/dL in the absence of transfusions.
- dispersion Type
- Full Range
- 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
- MEDIAN
- population Description
- ITT Population (all randomized participants regardless of whether or not the participant received treatment) who achieve HI-E response (Week 1-24)
- reporting Status
- POSTED
- time Frame
- Week 1 through Week 24
- title
- Time to Hematologic Improvement - Erythroid Response (HI-E)
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice