TriangleNCT03785964 · OUTCOME
Change From Baseline at Cycle 10 in the GOunder/Desmoid Tumor Research Tumor Foundation (DTRF) DEsmoid Tumor Symptom Scale (DTSS) - Total Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- score on a scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Daily for the last 7 days of every cycle (each cycle is 28 days) through study completion, an average of 2 years
What was measured
The DEsmoid Tumor Symptom Scale is an 11-point, numeric rating scale from 0 to 10 to measure severity from "none" to "as bad as you can imagine," with a 24-hour recall period. The Total Symptom Score is calculated as the mean of Pain items (Items 1-3) as a single score, then a mean of this with items 4-7). Weekly summary scores will be created by averaging the daily scores over the 7 days period prior to each visit. A weekly score will be derived only if 4 or more out of 7 days period have non-missing scores. The weekly summary score will be used in analyses. If no weekly summary score is calculable, the participant will have data considered as missing at that visit. Higher scores represent worse symptom severity. The minimum and maximum of the actual score are (0,7) for Nirogacestat and (0,10) for Placebo. A positive change from Baseline value indicated worsening of symptoms. The minimum and maximum of change from baseline are (-6,1) for Nirogacestat and (-4,5) for Placebo.
Analysis population: Intent-to-Treat Population
Groups in this outcome
Double-Blind Phase - Nirogacestat
Nirogacestat 150 mg by mouth, twice daily Nirogacestat oral tablet: Nirogacestat tablet
Double-Blind Phase - Placebo
Placebo by mouth, twice daily Placebo Oral Tablet: Sugar pill manufactured to mimic nirogacestat 50 mg tablet
| Group | Source count |
|---|---|
| Double-Blind Phase - Nirogacestat | 70 |
| Double-Blind Phase - Placebo | 72 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Double-Blind Phase - Nirogacestat | -1.110 | Not reported | -1.569 | -0.651 | Not reported |
| Double-Blind Phase - Placebo | 0.457 | Not reported | -0.009 | 0.923 | Not reported |
Source statistical analyses
- group Description
- Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline DEsmoid Tumor Symptom Scale score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 40 and 32 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- statistical Comment
- An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.
- statistical Method
- Mixed Models Analysis
Complete source fields
- analyses
- group Description
- Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline DEsmoid Tumor Symptom Scale score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 40 and 32 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- statistical Comment
- An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.
- statistical Method
- Mixed Models Analysis
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -1.569
- upper Limit
- -0.651
- value
- -1.110
- group Id
- OG001
- lower Limit
- -0.009
- upper Limit
- 0.923
- value
- 0.457
- denoms
- counts
- group Id
- OG000
- value
- 70
- group Id
- OG001
- value
- 72
- units
- Participants
- description
- The DEsmoid Tumor Symptom Scale is an 11-point, numeric rating scale from 0 to 10 to measure severity from "none" to "as bad as you can imagine," with a 24-hour recall period. The Total Symptom Score is calculated as the mean of Pain items (Items 1-3) as a single score, then a mean of this with items 4-7). Weekly summary scores will be created by averaging the daily scores over the 7 days period prior to each visit. A weekly score will be derived only if 4 or more out of 7 days period have non-missing scores. The weekly summary score will be used in analyses. If no weekly summary score is calculable, the participant will have data considered as missing at that visit. Higher scores represent worse symptom severity. The minimum and maximum of the actual score are (0,7) for Nirogacestat and (0,10) for Placebo. A positive change from Baseline value indicated worsening of symptoms. The minimum and maximum of change from baseline are (-6,1) for Nirogacestat and (-4,5) for Placebo.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nirogacestat 150 mg by mouth, twice daily Nirogacestat oral tablet: Nirogacestat tablet
- id
- OG000
- title
- Double-Blind Phase - Nirogacestat
- description
- Placebo by mouth, twice daily Placebo Oral Tablet: Sugar pill manufactured to mimic nirogacestat 50 mg tablet
- id
- OG001
- title
- Double-Blind Phase - Placebo
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Intent-to-Treat Population
- reporting Status
- POSTED
- time Frame
- Daily for the last 7 days of every cycle (each cycle is 28 days) through study completion, an average of 2 years
- title
- Change From Baseline at Cycle 10 in the GOunder/Desmoid Tumor Research Tumor Foundation (DTRF) DEsmoid Tumor Symptom Scale (DTSS) - Total Score
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice