TriangleNCT03682536 · OUTCOME
Time to First Red Blood Cell (RBC) Transfusion
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Week 1 through End of Treatment (Up to approximately an average of 66 weeks and a maximum of 202 weeks)
What was measured
Time to first RBC transfusion is defined as time from Week 1 to first RBC transfusion on treatment. Participants who maintain RBC-TI through the end of the Treatment Period or time of analysis will be censored at EOT visit date, subsequent MDS therapy start date, study discontinuation date, analysis cutoff date or death, whichever occurs first. Median is from un-stratified Kaplan-Meier method.
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 | 155.0 | Not reported | 80.0 | 266.0 | Not reported |
| Epoetin Alfa | 42.0 | Not reported | 23.0 | 55.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 80.0
- upper Limit
- 266.0
- value
- 155.0
- group Id
- OG001
- lower Limit
- 23.0
- upper Limit
- 55.0
- value
- 42.0
- denoms
- counts
- group Id
- OG000
- value
- 182
- group Id
- OG001
- value
- 181
- units
- Participants
- description
- Time to first RBC transfusion is defined as time from Week 1 to first RBC transfusion on treatment. Participants who maintain RBC-TI through the end of the Treatment Period or time of analysis will be censored at EOT visit date, subsequent MDS therapy start date, study discontinuation date, analysis cutoff date or death, whichever occurs first. Median is from un-stratified Kaplan-Meier method.
- 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
- MEDIAN
- population Description
- ITT Population - all randomized participants regardless of whether or not the participant received treatment.
- reporting Status
- POSTED
- time Frame
- Week 1 through End of Treatment (Up to approximately an average of 66 weeks and a maximum of 202 weeks)
- title
- Time to First Red Blood Cell (RBC) Transfusion
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice