TriangleNCT03785964 · OUTCOME
Change From Baseline at Cycle 10 in the Brief Pain Inventory (BPI) Average Pain Intensity (API) 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 Brief Pain Inventory consists of 9 questions and utilizes a 11-point Numerical pain Rating Scale from 0-10 measuring severity from "no pain" to "pain as bad as you can imagine," with a 24-hour recall period. Average Pain Intensity is calculated as the 7-day average (when results on at least 4 days for a VISIT are available) of Brief Pain Inventory Question #3 - Worst Pain in last 24 hours. A lower score indicates greater pain relief. The minimum and maximum of the actual score are (0, 8) for Nirogacestat and (0,9) for Placebo, respectively. A positive change from Baseline value indicates worsening of Average Pain Intensity and a negative change from Baseline value indicates improvement of Average Pain Intensity. The minimum and maximum of change from baseline score are (-7, 3) for Nirogacestat and (-5, 5) for Placebo, respectively.
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 | -1.583 | Not reported | -2.157 | -1.009 | Not reported |
| Double-Blind Phase - Placebo | -0.241 | Not reported | -0.822 | 0.340 | Not reported |
Source statistical analyses
- group Description
- Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline Brief Pain Inventory Short Form 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 31 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 Brief Pain Inventory Short Form 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 31 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
- -2.157
- upper Limit
- -1.009
- value
- -1.583
- group Id
- OG001
- lower Limit
- -0.822
- upper Limit
- 0.340
- value
- -0.241
- denoms
- counts
- group Id
- OG000
- value
- 70
- group Id
- OG001
- value
- 72
- units
- Participants
- description
- The Brief Pain Inventory consists of 9 questions and utilizes a 11-point Numerical pain Rating Scale from 0-10 measuring severity from "no pain" to "pain as bad as you can imagine," with a 24-hour recall period. Average Pain Intensity is calculated as the 7-day average (when results on at least 4 days for a VISIT are available) of Brief Pain Inventory Question #3 - Worst Pain in last 24 hours. A lower score indicates greater pain relief. The minimum and maximum of the actual score are (0, 8) for Nirogacestat and (0,9) for Placebo, respectively. A positive change from Baseline value indicates worsening of Average Pain Intensity and a negative change from Baseline value indicates improvement of Average Pain Intensity. The minimum and maximum of change from baseline score are (-7, 3) for Nirogacestat and (-5, 5) for Placebo, respectively.
- 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 Brief Pain Inventory (BPI) Average Pain Intensity (API) Score.
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice