TriangleNCT01422408 · OUTCOME
Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- units on a scale
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- Baseline and 4 weeks
What was measured
Association of response in symptoms with characteristics of the subject population (Dyspareunia and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Analysis population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Groups in this outcome
Supportive Care (Fluocinonide Cream)
This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
| Group | Source count |
|---|---|
| Supportive Care (Fluocinonide Cream) | 34 |
Reported measurements
Yes
| Group | Source count |
|---|---|
| Supportive Care (Fluocinonide Cream) | 14 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | -2 | Not reported | -2.25 | -1 | Not reported |
No
| Group | Source count |
|---|---|
| Supportive Care (Fluocinonide Cream) | 20 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | -2.5 | Not reported | -3 | -2 | Not reported |
Source statistical analyses
- group Description
- In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.5113
- p Value Comment
- No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
- statistical Comment
- Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
- statistical Method
- ANOVA
Complete source fields
- analyses
- group Description
- In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.5113
- p Value Comment
- No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
- statistical Comment
- Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
- statistical Method
- ANOVA
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -2.25
- upper Limit
- -1
- value
- -2
- denoms
- counts
- group Id
- OG000
- value
- 14
- units
- Participants
- title
- Yes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -3
- upper Limit
- -2
- value
- -2.5
- denoms
- counts
- group Id
- OG000
- value
- 20
- units
- Participants
- title
- No
- denoms
- counts
- group Id
- OG000
- value
- 34
- units
- Participants
- description
- Association of response in symptoms with characteristics of the subject population (Dyspareunia and prior cytotoxic therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
- dispersion Type
- Inter-Quartile Range
- groups
- description
- This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
- id
- OG000
- title
- Supportive Care (Fluocinonide Cream)
- param Type
- MEDIAN
- population Description
- The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
- reporting Status
- POSTED
- time Frame
- Baseline and 4 weeks
- title
- Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice