TriangleNCT02717507 · OUTCOME
Average Bilirubin
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- mg/dL
- Interval / dispersion
- Standard Error
- Time frame
- Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
What was measured
A liver function measurement (in mg/dL). The mean is reported by arm at each timepoint with corresponding standard errors.
Analysis population: We excluded 31 participants who did not have a second time point assessment of echocardiography, resulting in 151 analyzable participants.
Groups in this outcome
Arm I (Carvedilol)
Patients received Carvedilol PO delivered at 6.25 mg twice daily (for a total dose of 12.5 mg per day) for 24 months.
Arm II (Placebo)
Patients received Placebo PO delivered at 6.25 mg twice daily (for a total dose of 12.5 mg per day) for 24 months.
| Group | Source count |
|---|---|
| Arm I (Carvedilol) | 75 |
| Arm II (Placebo) | 76 |
Reported measurements
BL
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 0.5634 | 0.0428 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 0.4989 | 0.0272 | Not reported | Not reported | Not reported |
6m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 0.5973 | 0.0453 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 0.4942 | 0.0262 | Not reported | Not reported | Not reported |
12m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 0.563 | 0.0487 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 0.4969 | 0.0302 | Not reported | Not reported | Not reported |
18m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 0.593 | 0.0665 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 0.507 | 0.04 | Not reported | Not reported | Not reported |
24m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 0.5561 | 0.0436 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 0.5449 | 0.0354 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.18
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.229
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.104
- estimate Comment
- The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.82
- param Type
- Slope
- param Value
- 0.024
- statistical Comment
- The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.
- statistical Method
- Generalized Estimating Equation (GEE)
Complete source fields
- analyses
- ci Lower Limit
- -0.18
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.229
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.104
- estimate Comment
- The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.82
- param Type
- Slope
- param Value
- 0.024
- statistical Comment
- The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.
- statistical Method
- Generalized Estimating Equation (GEE)
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.0428
- value
- 0.5634
- group Id
- OG001
- spread
- 0.0272
- value
- 0.4989
- title
- BL
- categories
- measurements
- group Id
- OG000
- spread
- 0.0453
- value
- 0.5973
- group Id
- OG001
- spread
- 0.0262
- value
- 0.4942
- title
- 6m
- categories
- measurements
- group Id
- OG000
- spread
- 0.0487
- value
- 0.563
- group Id
- OG001
- spread
- 0.0302
- value
- 0.4969
- title
- 12m
- categories
- measurements
- group Id
- OG000
- spread
- 0.0665
- value
- 0.593
- group Id
- OG001
- spread
- 0.04
- value
- 0.507
- title
- 18m
- categories
- measurements
- group Id
- OG000
- spread
- 0.0436
- value
- 0.5561
- group Id
- OG001
- spread
- 0.0354
- value
- 0.5449
- title
- 24m
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 76
- units
- Participants
- description
- A liver function measurement (in mg/dL). The mean is reported by arm at each timepoint with corresponding standard errors.
- dispersion Type
- Standard Error
- groups
- description
- Patients received Carvedilol PO delivered at 6.25 mg twice daily (for a total dose of 12.5 mg per day) for 24 months.
- id
- OG000
- title
- Arm I (Carvedilol)
- description
- Patients received Placebo PO delivered at 6.25 mg twice daily (for a total dose of 12.5 mg per day) for 24 months.
- id
- OG001
- title
- Arm II (Placebo)
- param Type
- MEAN
- population Description
- We excluded 31 participants who did not have a second time point assessment of echocardiography, resulting in 151 analyzable participants.
- reporting Status
- POSTED
- time Frame
- Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
- title
- Average Bilirubin
- type
- SECONDARY
- unit Of Measure
- mg/dL
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Preserved source evidence · Not medical advice