TriangleNCT00410514 · OUTCOME
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Storage Symptom Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- scores on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Baseline and Weeks 1, 4, 8 and 12
What was measured
The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 questions relating to storage symptoms (frequency, urgency and nocturia) and ranges from 0 to 15 (asymptomatic to very symptomatic). Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate.
Analysis population: The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug \& had both Qmax \& PdetQmax measurements at baseline \& 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.
Groups in this outcome
Placebo
Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
Mirabegron 50 mg
Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
Mirabegron 100 mg
Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
| Group | Source count |
|---|---|
| Placebo | 63 |
| Mirabegron 50 mg | 64 |
| Mirabegron 100 mg | 58 |
Reported measurements
Change from Baseline at Week 1 [N=63; 63; 57]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | -0.7 | 0.25 | Not reported | Not reported | Not reported |
| Mirabegron 50 mg | -1.4 | 0.25 | Not reported | Not reported | Not reported |
| Mirabegron 100 mg | -1.0 | 0.26 | Not reported | Not reported | Not reported |
Change from Baseline at Week 4 [N=63; 62; 58]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | -1.7 | 0.31 | Not reported | Not reported | Not reported |
| Mirabegron 50 mg | -2.6 | 0.31 | Not reported | Not reported | Not reported |
| Mirabegron 100 mg | -2.3 | 0.33 | Not reported | Not reported | Not reported |
Change from Baseline at Week 8 [N=62; 63; 57]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | -2.1 | 0.33 | Not reported | Not reported | Not reported |
| Mirabegron 50 mg | -3.2 | 0.32 | Not reported | Not reported | Not reported |
| Mirabegron 100 mg | -2.6 | 0.35 | Not reported | Not reported | Not reported |
Change from Baseline at Week 12 [N=59; 61; 52]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | -2.2 | 0.36 | Not reported | Not reported | Not reported |
| Mirabegron 50 mg | -3.4 | 0.35 | Not reported | Not reported | Not reported |
| Mirabegron 100 mg | -2.5 | 0.39 | Not reported | Not reported | Not reported |
Change from Baseline at EOT [N=63; 64; 58]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | -2.2 | 0.34 | Not reported | Not reported | Not reported |
| Mirabegron 50 mg | -3.3 | 0.34 | Not reported | Not reported | Not reported |
| Mirabegron 100 mg | -2.5 | 0.36 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.25
- value
- -0.7
- group Id
- OG001
- spread
- 0.25
- value
- -1.4
- group Id
- OG002
- spread
- 0.26
- value
- -1.0
- title
- Change from Baseline at Week 1 [N=63; 63; 57]
- categories
- measurements
- group Id
- OG000
- spread
- 0.31
- value
- -1.7
- group Id
- OG001
- spread
- 0.31
- value
- -2.6
- group Id
- OG002
- spread
- 0.33
- value
- -2.3
- title
- Change from Baseline at Week 4 [N=63; 62; 58]
- categories
- measurements
- group Id
- OG000
- spread
- 0.33
- value
- -2.1
- group Id
- OG001
- spread
- 0.32
- value
- -3.2
- group Id
- OG002
- spread
- 0.35
- value
- -2.6
- title
- Change from Baseline at Week 8 [N=62; 63; 57]
- categories
- measurements
- group Id
- OG000
- spread
- 0.36
- value
- -2.2
- group Id
- OG001
- spread
- 0.35
- value
- -3.4
- group Id
- OG002
- spread
- 0.39
- value
- -2.5
- title
- Change from Baseline at Week 12 [N=59; 61; 52]
- categories
- measurements
- group Id
- OG000
- spread
- 0.34
- value
- -2.2
- group Id
- OG001
- spread
- 0.34
- value
- -3.3
- group Id
- OG002
- spread
- 0.36
- value
- -2.5
- title
- Change from Baseline at EOT [N=63; 64; 58]
- denoms
- counts
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 64
- group Id
- OG002
- value
- 58
- units
- Participants
- description
- The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 questions relating to storage symptoms (frequency, urgency and nocturia) and ranges from 0 to 15 (asymptomatic to very symptomatic). Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate.
- dispersion Type
- Standard Error
- groups
- description
- Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
- id
- OG000
- title
- Placebo
- description
- Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
- id
- OG001
- title
- Mirabegron 50 mg
- description
- Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
- id
- OG002
- title
- Mirabegron 100 mg
- param Type
- LEAST_SQUARES_MEAN
- population Description
- The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug \& had both Qmax \& PdetQmax measurements at baseline \& 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.
- reporting Status
- POSTED
- time Frame
- Baseline and Weeks 1, 4, 8 and 12
- title
- Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Storage Symptom Score
- type
- SECONDARY
- unit Of Measure
- scores on a scale
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Preserved source evidence · Not medical advice