TriangleNCT00931528 · OUTCOME
Overall Patient Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire (SAQ) Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- change in SAQ score
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, week 30 and years 1 and 2 after the start of treatment
What was measured
The Sexual Adjustment Questionnaire (SAQ) is a 20-item questionnaire with an overall score range between 8 and 100 including the following domains: desire, ranging between 5 and 30; dysfunction, 0 and 25; activity, 0 and 10; satisfaction, 1 and 10; and fatigue, 1 and 5. The change in SAQ score is calculated by subtracting the baseline score from the follow-up score. A positive change indicates an improvement in sexual well-being.
Analysis population: Eligible patients with data at baseline and corresponding time point
Groups in this outcome
Tadalafil
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
Placebo
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
| Group | Source count |
|---|---|
| Tadalafil | 63 |
| Placebo | 51 |
Reported measurements
Week 30
| Group | Source count |
|---|---|
| Tadalafil | 47 |
| Placebo | 35 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tadalafil | -2.0 | 11.3 | Not reported | Not reported | Not reported |
| Placebo | -2.9 | 8.0 | Not reported | Not reported | Not reported |
Year 1
| Group | Source count |
|---|---|
| Tadalafil | 36 |
| Placebo | 24 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tadalafil | -3.7 | 9.7 | Not reported | Not reported | Not reported |
| Placebo | -4.9 | 9.9 | Not reported | Not reported | Not reported |
Year 2
| Group | Source count |
|---|---|
| Tadalafil | 31 |
| Placebo | 28 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tadalafil | -3.4 | 9.3 | Not reported | Not reported | Not reported |
| Placebo | -4.6 | 14.8 | Not reported | Not reported | Not reported |
Source statistical analyses
- group Description
- Week 30
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.70
- statistical Comment
- Significance level = 0.05
- statistical Method
- t-test, 2 sided
- group Description
- Year 1
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.65
- statistical Comment
- Significance level = 0.05
- statistical Method
- t-test, 2 sided
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.72
- statistical Comment
- Significance level = 0.05
- statistical Method
- t-test, 2 sided
Complete source fields
- analyses
- group Description
- Week 30
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.70
- statistical Comment
- Significance level = 0.05
- statistical Method
- t-test, 2 sided
- group Description
- Year 1
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.65
- statistical Comment
- Significance level = 0.05
- statistical Method
- t-test, 2 sided
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.72
- statistical Comment
- Significance level = 0.05
- statistical Method
- t-test, 2 sided
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 11.3
- value
- -2.0
- group Id
- OG001
- spread
- 8.0
- value
- -2.9
- denoms
- counts
- group Id
- OG000
- value
- 47
- group Id
- OG001
- value
- 35
- units
- Participants
- title
- Week 30
- categories
- measurements
- group Id
- OG000
- spread
- 9.7
- value
- -3.7
- group Id
- OG001
- spread
- 9.9
- value
- -4.9
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 24
- units
- Participants
- title
- Year 1
- categories
- measurements
- group Id
- OG000
- spread
- 9.3
- value
- -3.4
- group Id
- OG001
- spread
- 14.8
- value
- -4.6
- denoms
- counts
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 28
- units
- Participants
- title
- Year 2
- denoms
- counts
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 51
- units
- Participants
- description
- The Sexual Adjustment Questionnaire (SAQ) is a 20-item questionnaire with an overall score range between 8 and 100 including the following domains: desire, ranging between 5 and 30; dysfunction, 0 and 25; activity, 0 and 10; satisfaction, 1 and 10; and fatigue, 1 and 5. The change in SAQ score is calculated by subtracting the baseline score from the follow-up score. A positive change indicates an improvement in sexual well-being.
- dispersion Type
- Standard Deviation
- groups
- description
- Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
- id
- OG000
- title
- Tadalafil
- description
- Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
- id
- OG001
- title
- Placebo
- param Type
- MEAN
- population Description
- Eligible patients with data at baseline and corresponding time point
- reporting Status
- POSTED
- time Frame
- Baseline, week 30 and years 1 and 2 after the start of treatment
- title
- Overall Patient Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire (SAQ) Score
- type
- SECONDARY
- unit Of Measure
- change in SAQ score
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Preserved source evidence · Not medical advice