TriangleNCT02604433 · OUTCOME
Longest Duration of Transfusion Independence
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
- From first dose through 3 weeks post last dose (up to approximately 218 weeks)
What was measured
Transfusion independence was defined as the absence of any transfusion during any consecutive "rolling" 8-week time interval within the treatment period, ie, Days 1 to 56, Days 2 to 57 and so on. Longest duration of transfusion independence was estimated based on Kaplan-Meier model.
Analysis population: All randomized participants who were transfusion independent for ≥ 8 weeks
Groups in this outcome
Luspatercept + BSC
Luspatercept (ACE-536) was administered subcutaneously (SC) at a starting dose level of 1 mg/kg once every 21 days. Participants could be dose-titrated to 1.25 mg/kg, but the maximum total dose should not exceed 120 mg, total dose per administration during the Treatment Period, the Long-term Treatment Period, and Open-Label Treatment Period. BSC = Best Supportive Care
Placebo + BSC
Placebo (normal saline) was administered subcutaneously (SC) in volumes to match active treatment once every 21 days. BSC = Best Supportive Care
| Group | Source count |
|---|---|
| Luspatercept + BSC | 27 |
| Placebo + BSC | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Luspatercept + BSC | 72.0 | Not reported | 62.0 | 103.0 | Not reported |
| Placebo + BSC | 71.5 | Not reported | 62.0 | NA | Insufficient number of events to determine the upper limit |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 62.0
- upper Limit
- 103.0
- value
- 72.0
- comment
- Insufficient number of events to determine the upper limit
- group Id
- OG001
- lower Limit
- 62.0
- upper Limit
- NA
- value
- 71.5
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 2
- units
- Participants
- description
- Transfusion independence was defined as the absence of any transfusion during any consecutive "rolling" 8-week time interval within the treatment period, ie, Days 1 to 56, Days 2 to 57 and so on. Longest duration of transfusion independence was estimated based on Kaplan-Meier model.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Luspatercept (ACE-536) was administered subcutaneously (SC) at a starting dose level of 1 mg/kg once every 21 days. Participants could be dose-titrated to 1.25 mg/kg, but the maximum total dose should not exceed 120 mg, total dose per administration during the Treatment Period, the Long-term Treatment Period, and Open-Label Treatment Period. BSC = Best Supportive Care
- id
- OG000
- title
- Luspatercept + BSC
- description
- Placebo (normal saline) was administered subcutaneously (SC) in volumes to match active treatment once every 21 days. BSC = Best Supportive Care
- id
- OG001
- title
- Placebo + BSC
- param Type
- MEDIAN
- population Description
- All randomized participants who were transfusion independent for ≥ 8 weeks
- reporting Status
- POSTED
- time Frame
- From first dose through 3 weeks post last dose (up to approximately 218 weeks)
- title
- Longest Duration of Transfusion Independence
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice