TriangleNCT02604433 · OUTCOME
Percentage of Participants Who Achieved Erythroid Response - Week 13 to Week 24
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline: Day -83 to Day 1; Treatment: Weeks 13 to Week 24
What was measured
Erythroid Response was defined as red blood cell (RBC) transfusion burden reduction from baseline ≥ 33% with a reduction of at least 2 units during Week 13 - 24 compared to the 12-week interval on or prior to Dose 1 Day 1.
Analysis population: All randomized participants
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 | 224 |
| Placebo + BSC | 112 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Luspatercept + BSC | 21.0 | Not reported | Not reported | Not reported | Not reported |
| Placebo + BSC | 4.5 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 2.17
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 14.53
- group Description
- Odds ratio 95% confidence intervals (CIs), and p-value were estimated from the Cochran Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Significance level of 0.050 for 2-sided tests.
- param Type
- Odds Ratio (OR)
- param Value
- 5.62
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 10.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 23.1
- estimate Comment
- Luspatercept - Placebo
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Difference in Percentages
- param Value
- 16.5
- ci Lower Limit
- 9.9
- ci Pct Value
- 95
- ci Upper Limit
- 23.1
- estimate Comment
- Luspatercept - Placebo
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Common Risk Difference
- param Value
- 16.5
Complete source fields
- analyses
- ci Lower Limit
- 2.17
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 14.53
- group Description
- Odds ratio 95% confidence intervals (CIs), and p-value were estimated from the Cochran Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Significance level of 0.050 for 2-sided tests.
- param Type
- Odds Ratio (OR)
- param Value
- 5.62
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 10.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 23.1
- estimate Comment
- Luspatercept - Placebo
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Difference in Percentages
- param Value
- 16.5
- ci Lower Limit
- 9.9
- ci Pct Value
- 95
- ci Upper Limit
- 23.1
- estimate Comment
- Luspatercept - Placebo
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Common Risk Difference
- param Value
- 16.5
- classes
- categories
- measurements
- group Id
- OG000
- value
- 21.0
- group Id
- OG001
- value
- 4.5
- denoms
- counts
- group Id
- OG000
- value
- 224
- group Id
- OG001
- value
- 112
- units
- Participants
- description
- Erythroid Response was defined as red blood cell (RBC) transfusion burden reduction from baseline ≥ 33% with a reduction of at least 2 units during Week 13 - 24 compared to the 12-week interval on or prior to Dose 1 Day 1.
- 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
- NUMBER
- population Description
- All randomized participants
- reporting Status
- POSTED
- time Frame
- Baseline: Day -83 to Day 1; Treatment: Weeks 13 to Week 24
- title
- Percentage of Participants Who Achieved Erythroid Response - Week 13 to Week 24
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice