TriangleNCT00410514 · OUTCOME
Change From Baseline to End of Treatment in Bladder Contractile Index (BCI)
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 Week 12
What was measured
The Bladder Contractile Index (BCI) is a value used to measure the degree of contractility. BCI was calculated using the following formula: BCI = pdetQmax + 5Qmax. Strong contractility is a BCI \> 150, normal contractility is a BCI of 100-150 and weak contractility is a BCI of \< 100. 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. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.
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 | 57 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 1.25 | 3.363 | Not reported | Not reported | Not reported |
| Mirabegron 50 mg | -2.60 | 3.324 | Not reported | Not reported | Not reported |
| Mirabegron 100 mg | 2.51 | 3.567 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.363
- value
- 1.25
- group Id
- OG001
- spread
- 3.324
- value
- -2.60
- group Id
- OG002
- spread
- 3.567
- value
- 2.51
- denoms
- counts
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 64
- group Id
- OG002
- value
- 57
- units
- Participants
- description
- The Bladder Contractile Index (BCI) is a value used to measure the degree of contractility. BCI was calculated using the following formula: BCI = pdetQmax + 5Qmax. Strong contractility is a BCI \> 150, normal contractility is a BCI of 100-150 and weak contractility is a BCI of \< 100. 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. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.
- reporting Status
- POSTED
- time Frame
- Baseline and Week 12
- title
- Change From Baseline to End of Treatment in Bladder Contractile Index (BCI)
- type
- SECONDARY
- unit Of Measure
- Scores on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice