TriangleNCT03785964 · OUTCOME
Change From Baseline at Cycle10 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Scale.
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
- Last day of every cycle (each cycle is 28 days) through study completion, an average of 2 years
What was measured
The EORTC Quality of Life Questionnaire-Core 30 version 3.0 was used with a 7-day recall period. It consists of 30 questions with all items scored 1 ("not at all") to 4 ("very much") except for the 2 items contributing to the global health status/QoL, which are scored 1 ("very poor") to 7 ("excellent"). The instrument yields the following scales:5 functional scales, 3 symptom scales, and a global health status/quality of life scale. A high score for the global health status/QoL represents a high QoL. The minimum and maximum of the actual score are (33, 100) for Nirogacestat and (8,92) for Placebo, respectively. A positive change from baseline indicated improvement of global health status and a negative change from baseline value indicated worsening of global health status. The minimum and maximum of change from baseline score are (-58, 67) for Nirogacestat and (-67, 42) 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 | 2.935 | Not reported | -3.115 | 8.985 | Not reported |
| Double-Blind Phase - Placebo | -8.466 | Not reported | -15.065 | -1.867 | Not reported |
Source statistical analyses
- group Description
- Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline 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. 38 and 27 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.006
- 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 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. 38 and 27 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.006
- 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
- -3.115
- upper Limit
- 8.985
- value
- 2.935
- group Id
- OG001
- lower Limit
- -15.065
- upper Limit
- -1.867
- value
- -8.466
- denoms
- counts
- group Id
- OG000
- value
- 70
- group Id
- OG001
- value
- 72
- units
- Participants
- description
- The EORTC Quality of Life Questionnaire-Core 30 version 3.0 was used with a 7-day recall period. It consists of 30 questions with all items scored 1 ("not at all") to 4 ("very much") except for the 2 items contributing to the global health status/QoL, which are scored 1 ("very poor") to 7 ("excellent"). The instrument yields the following scales:5 functional scales, 3 symptom scales, and a global health status/quality of life scale. A high score for the global health status/QoL represents a high QoL. The minimum and maximum of the actual score are (33, 100) for Nirogacestat and (8,92) for Placebo, respectively. A positive change from baseline indicated improvement of global health status and a negative change from baseline value indicated worsening of global health status. The minimum and maximum of change from baseline score are (-58, 67) for Nirogacestat and (-67, 42) 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
- Last day of every cycle (each cycle is 28 days) through study completion, an average of 2 years
- title
- Change From Baseline at Cycle10 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Scale.
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice