TriangleNCT02604433 · OUTCOME
Mean Change From Baseline In Liver Iron Concentration (LIC) At Week 48
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- mg/g dry weight
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline: Week -12 to Day -1; Treatment: Week 48
What was measured
Baseline was defined as the last value on or before the first dose of study drug was administered; if multiple values were present for the same date, the average of these values was used. If a participant had 1 postbaseline assessment, it was used as the Week 48 value. If a participant had multiple postbaseline assessments, the last one was used as the Week 48 value. The value of LIC was collected by magnetic resonance imaging. Participants with a LIC value \> 43 mg/g were not included in the analysis.
Analysis population: All randomized participants with available measurements at the specified timepoints
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 | 185 |
| Placebo + BSC | 99 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Luspatercept + BSC | 0.05 | 5.770 | Not reported | Not reported | Not reported |
| Placebo + BSC | -0.00 | 5.329 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -1.10
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.51
- estimate Comment
- luspatercept - placebo
- group Description
- Change from baseline at Week 48 P-value ANCOVA model with geographical regions defined at randomization and baseline LIC as covariates. LS = least square
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7598
- p Value Comment
- Significance level of 0.050 for 2-sided tests.
- param Type
- LS Mean of Difference
- param Value
- 0.20
- statistical Method
- ANCOVA
Complete source fields
- analyses
- ci Lower Limit
- -1.10
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.51
- estimate Comment
- luspatercept - placebo
- group Description
- Change from baseline at Week 48 P-value ANCOVA model with geographical regions defined at randomization and baseline LIC as covariates. LS = least square
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7598
- p Value Comment
- Significance level of 0.050 for 2-sided tests.
- param Type
- LS Mean of Difference
- param Value
- 0.20
- statistical Method
- ANCOVA
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 5.770
- value
- 0.05
- group Id
- OG001
- spread
- 5.329
- value
- -0.00
- denoms
- counts
- group Id
- OG000
- value
- 185
- group Id
- OG001
- value
- 99
- units
- Participants
- description
- Baseline was defined as the last value on or before the first dose of study drug was administered; if multiple values were present for the same date, the average of these values was used. If a participant had 1 postbaseline assessment, it was used as the Week 48 value. If a participant had multiple postbaseline assessments, the last one was used as the Week 48 value. The value of LIC was collected by magnetic resonance imaging. Participants with a LIC value \> 43 mg/g were not included in the analysis.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- All randomized participants with available measurements at the specified timepoints
- reporting Status
- POSTED
- time Frame
- Baseline: Week -12 to Day -1; Treatment: Week 48
- title
- Mean Change From Baseline In Liver Iron Concentration (LIC) At Week 48
- type
- SECONDARY
- unit Of Measure
- mg/g dry weight
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice