TriangleNCT02632786 · OUTCOME
NT-proBNP Slope
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/L per infusion
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline through 12 months of treatment
What was measured
Rate of change in NT-proBNP (ng/L per infusion). Estimates of the intercept, slope, SE, and associated 95% CI for each treatment group, and the NEOD001 and placebo group difference comparisons are estimated using a general linear mixed effects model. The model fits a random intercept and slope for each subject and includes fixed effects for treatment group, time, treatment group by time interaction, IWRS stratification factors (hematologic response to first-line therapy: CR/VGPR, PR and NT-proBNP \<1800 ng/L, ≥1800 ng/L), and an unstructured covariance structure to model the within-subject errors. Time is represented in months as a continuous variable and includes all scheduled time points, including baseline. The p-value is associated with the visit by treatment group interaction term.
Analysis population: ITT population
Groups in this outcome
NEOD001 24 mg/kg
NEOD001, 24 mg/kg IV every 4 weeks for 12 months
Placebo
Placebo, 0.9% Saline IV every 4 weeks for 12 months
| Group | Source count |
|---|---|
| NEOD001 24 mg/kg | 66 |
| Placebo | 63 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NEOD001 24 mg/kg | 9.45 | Not reported | -45.66 | 64.55 | Not reported |
| Placebo | 81.41 | Not reported | 25.15 | 137.68 | Not reported |
Source statistical analyses
- ci Lower Limit
- -150.72
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 6.79
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0729
- param Type
- Slope
- param Value
- -71.97
- statistical Method
- Mixed Models Analysis
Complete source fields
- analyses
- ci Lower Limit
- -150.72
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 6.79
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0729
- param Type
- Slope
- param Value
- -71.97
- statistical Method
- Mixed Models Analysis
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -45.66
- upper Limit
- 64.55
- value
- 9.45
- group Id
- OG001
- lower Limit
- 25.15
- upper Limit
- 137.68
- value
- 81.41
- denoms
- counts
- group Id
- OG000
- value
- 66
- group Id
- OG001
- value
- 63
- units
- Participants
- description
- Rate of change in NT-proBNP (ng/L per infusion). Estimates of the intercept, slope, SE, and associated 95% CI for each treatment group, and the NEOD001 and placebo group difference comparisons are estimated using a general linear mixed effects model. The model fits a random intercept and slope for each subject and includes fixed effects for treatment group, time, treatment group by time interaction, IWRS stratification factors (hematologic response to first-line therapy: CR/VGPR, PR and NT-proBNP \<1800 ng/L, ≥1800 ng/L), and an unstructured covariance structure to model the within-subject errors. Time is represented in months as a continuous variable and includes all scheduled time points, including baseline. The p-value is associated with the visit by treatment group interaction term.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- NEOD001, 24 mg/kg IV every 4 weeks for 12 months
- id
- OG000
- title
- NEOD001 24 mg/kg
- description
- Placebo, 0.9% Saline IV every 4 weeks for 12 months
- id
- OG001
- title
- Placebo
- param Type
- MEAN
- population Description
- ITT population
- reporting Status
- POSTED
- time Frame
- Baseline through 12 months of treatment
- title
- NT-proBNP Slope
- type
- SECONDARY
- unit Of Measure
- ng/L per infusion
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice