TriangleNCT00099047 · OUTCOME
Changes in M-protein Levels
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- g/dL
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and 6 months
What was measured
For a given biomarker (or a suitable transformation of it, e.g. log transform) t-tests and Wilcoxon tests (2-sample t-test and Wilcoxon rank sum test for between treatment comparisons, and paired 1-sample t-test and Wilcoxon signed rank test for within treatment comparisons) will be used to detect statistically significant differences between (or within) treatments.
Analysis population: One patient on the celecoxib arm was considered inevaluable and not included in this participants analyzed.
Groups in this outcome
Arm I (Celecoxib)
Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
Arm II (Placebo)
Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
| Group | Source count |
|---|---|
| Arm I (Celecoxib) | 10 |
| Arm II (Placebo) | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Celecoxib) | 1.65 | 0.36 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 2.24 | 0.36 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- dispersion Type
- STANDARD_DEVIATION
- dispersion Value
- .05
- estimate Comment
- 36 evaluable patients randomized 1:1 to each treatment was planned in order to have \>77% power to detect differences in above parameters equal to or greater than one standard deviation, based on a 2-sided Wilcoxon rank-sum test with .05 Type I error.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- .23
- param Type
- Median Difference (Final Values)
- param Value
- .05
- statistical Method
- SAS version 8
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- dispersion Type
- STANDARD_DEVIATION
- dispersion Value
- .05
- estimate Comment
- 36 evaluable patients randomized 1:1 to each treatment was planned in order to have \>77% power to detect differences in above parameters equal to or greater than one standard deviation, based on a 2-sided Wilcoxon rank-sum test with .05 Type I error.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- .23
- param Type
- Median Difference (Final Values)
- param Value
- .05
- statistical Method
- SAS version 8
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.36
- value
- 1.65
- group Id
- OG001
- spread
- 0.36
- value
- 2.24
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- For a given biomarker (or a suitable transformation of it, e.g. log transform) t-tests and Wilcoxon tests (2-sample t-test and Wilcoxon rank sum test for between treatment comparisons, and paired 1-sample t-test and Wilcoxon signed rank test for within treatment comparisons) will be used to detect statistically significant differences between (or within) treatments.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
- id
- OG000
- title
- Arm I (Celecoxib)
- description
- Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
- id
- OG001
- title
- Arm II (Placebo)
- param Type
- MEDIAN
- population Description
- One patient on the celecoxib arm was considered inevaluable and not included in this participants analyzed.
- reporting Status
- POSTED
- time Frame
- Baseline and 6 months
- title
- Changes in M-protein Levels
- type
- PRIMARY
- unit Of Measure
- g/dL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice