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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20202160 | Registry Identifier | chinadrugtrials.org.cn |
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The purpose of this study was to evaluate the efficacy of mirabegron for the treatment of overactive bladder (OAB) in Chinese participants. This study also evaluated the safety of mirabegron for the treatment of OAB in Chinese participants, evaluated other efficacy variables of mirabegron for the treatment of OAB and explored different mirabegron starting doses.
The study followed an open-label, randomized, 12-week, prospective, interventional post-authorization design for the treatment of OAB in 249 Chinese participants. Each eligible participant took part in a 12-week treatment period. Treatments were administered once daily orally after a meal during a 12-week, open-label treatment period. Study visits took place at weeks 4, 8 and 12. For the 25 mg mirabegron group, a dose escalation to 50 mg was permitted on visit 3 and visit 4 at the investigators' discretion. 15 study sites across China enrolled participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirabegron 25 mg | Experimental | Participants received single oral dose of Mirabegron 25 milligrams (mg) tablet once daily, at the same time after a meal for a duration of 12 weeks. Dose escalation to 50 mg was permitted at Visit 3 (Week 4) or Visit 4 (Week 8) at the discretion of investigator. |
|
| Mirabegron 50 mg | Experimental | Participants received single oral dose of Mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mirabegron | Drug | Mirabegron was administered as single oral dose of 25 mg or 50 mg sustained-release tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (CFB) to the End of 12-Week Treatment Period in Mean Number of Micturition/24 Hours in Mirabegron 50 mg Group | A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period. | Baseline, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | AE was defined as any untoward medical occurrence in a participant administered a study drug or had undergone study procedures and which did not necessarily have had a causal relationship with the treatment. An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, Electrocardiography (ECG) data, and physical exam) was defined as an AE only if the abnormality induced clinical signs or symptoms or requires active intervention or requires interruption or discontinuation of study medication or the abnormality or investigational value was clinically significant in the opinion of the investigator. Treatment emergent AE was defined as an AE observed after starting administration of the IP and 30 days after the final administration of study drug. |
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Inclusion Criteria:
Participant should exhibit symptoms of OAB for at least 12 weeks before initiation of the screening period.
Participant should have an average of ≥ 8 micturitions/24 hours.
Participant should have an average of ≥ 1 episode of grade 3 or 4 (PPIUS) urgency or urgency incontinence/24 hours, during a 3-day micturition diary period.
Female participant is not pregnant and at least one of the following conditions apply:
Female participant must agree not to breastfeed starting at screening and throughout the study period and for 30 days after final IP administration.
Female participant must not donate ova starting at first dose of investigational product (IP) and throughout the study period and for 30 days after final IP administration.
Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and 30 days after final IP administration.
Male participant must not donate sperm during the treatment period and for 30 days after final IP administration.
Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 30 days after final IP administration.
Participant agrees not to participate in another interventional study while participating in the present study, defined as 28 days prior screening until completion of the last study visit.
Exclusion Criteria:
Exclusion at Visit 1/Week -2 (Screening)
Additional Exclusion at Visit 2/Week 0 (Baseline)
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| Name | Affiliation | Role |
|---|---|---|
| Executive Director | Astellas Pharma China, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site CN86020 | Wuhan | Hubei | China | |||
| Site CN86001 |
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| Label | URL |
|---|---|
| Link to plain language summary of the study on the Trial Results Summaries website | View source |
| Link to results and other applicable study documents on the Astellas Clinical Trials website | View source |
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Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Participants with symptoms of overactive bladder (OAB) for at least 12 weeks before initiation of the screening period and who met all of the inclusion and none of the exclusion criteria were enrolled in this study.
Participants were enrolled at study sites in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mirabegron 25 mg | Participants received single oral dose of mirabegron 25 milligrams (mg) tablet once daily, at the same time after a meal for a duration of 12 weeks. Dose escalation to 50 mg was permitted at Visit 3 (Week 4) or Visit 4 (Week 8) at the discretion of investigator. |
| FG001 | Mirabegron 50 mg | Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All Randomized Set consisted of all participants who were randomized and had a randomization number.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mirabegron 25 mg | Participants received single oral dose of mirabegron 25 mg tablet once daily, at the same time after a meal for a duration of 12 weeks. Dose escalation to 50 mg was permitted at Visit 3 (Week 4) or Visit 4 (Week 8) at the discretion of investigator. |
| BG001 | Mirabegron 50 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline (CFB) to the End of 12-Week Treatment Period in Mean Number of Micturition/24 Hours in Mirabegron 50 mg Group | A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period. | Full Analysis set (FAS) included all participants who were randomized and received at least 1 dose of investigational product (IP) and had at least 1 post baseline measurement for mean number of micturitions per 24 hours. Participants with available data were analyzed. | Posted | Mean | Standard Deviation | micturitions per 24 hours | Baseline, week 12 |
|
From first dose up to 30 days after last dose (up to Week 16)
SAF consisted of all participants who took at least 1 dose of IP.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mirabegron 25 mg (Never Up-titrated) | Participants who received single oral dose of mirabegron 25 mg tablet once daily, at the same time after a meal for a duration of 12 weeks and were never up-titrated to receive Mirabegron 50 mg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial ischaemia | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Transparency | Astellas Pharma China, Inc. | +86-(0)10-85216666 | astellas.resultsdisclosure@astellas.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 22, 2021 | Mar 4, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 19, 2022 | Mar 4, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
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Participants fulfilling the screening inclusion/exclusion criteria were randomized in a 2:1 ratio, 50 mg mirabegron and 25 mg mirabegron, using a computer-generated randomization to reduce selection bias.
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This was an open label study.
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| From first dose up to 30 days after last dose (up to week 16) |
| Change From Baseline to Week 12 in Post Void Residual (PVR) Volume | PVR was assessed by ultrasonography. | Baseline, week 12 |
| Change From Baseline in Mean Number of Grade 3 or 4 Patient Perception of Intensity of Urgency Scale (PPIUS) Urgency Episodes Per 24 Hours | Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which was difficult to defer. An urgency episode was defined as any micturition or incontinence episode with a severity of grade 3 or 4, assessed by participants based on the PPIUS, where grade 0 = No urgency; grade 1 = Mild urgency; grade 2 = Moderate urgency, could delay voiding a short while; grade 3 = Severe urgency, could not delay voiding; grade 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per day was calculated as the average number of times a participant recorded an urgency episode (grade 3 and/or 4) with or without incontinence per day during the 3-day micturition diary period. | Baseline and weeks 4, 8, and 12 |
| Change From Baseline in Mean Number of Daytime Incontinence Episodes Per 24 Hours | An incontinence episode was defined as an episode with any involuntary loss of urine. Daytime was defined as time between waking up in the morning and going to sleep later the same day or next day. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and at various specified time-intervals. | Baseline and weeks 4, 8, and 12 |
| Change From Baseline in Mean Number of Nighttime Incontinence Episodes Per 24 Hours | An incontinence episode was defined as an episode with any involuntary loss of urine. Nightime was defined as time between between going to sleep on a day and waking up on the same or next day. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and at various specified time-intervals. | Baseline and weeks 4, 8, and 12 |
| Change From Baseline in Mean Number of Urge Incontinence Episodes Per 24 Hours | An incontinence episode was defined as an episode with any involuntary loss of urine. The mean number of urge incontinence episodes per 24 hours was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and at various specified time-intervals. | Baseline and weeks 4, 8, and 12 |
| Change From Baseline in OAB Symptom Score (OABSS) | The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms: Daytime Frequency ("How many times do you typically urinate from waking in the morning until sleeping at night?" where scores range from 0-2), Nighttime Frequency ("How many times do you typically wake up to urinate from sleeping at night until waking in the morning?" where scores range from 0-3), Urgency ("How often do you have a sudden desire to urinate, which is difficult to defer?" where scores range from 0-5), Urgency Incontinence ("How often do you leak urine because you cannot defer the sudden desire to urinate?" where scores range from 0-5). The total score ranges from 0 to 15 with higher score indicating more symptoms. | Baseline and weeks 4, 8, and 12 |
| Change From Baseline in Mean Number of Micturition Per 24 Hours | A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period. | Baseline and weeks 4 and 8 |
| Beijing |
| China |
| Site CN86004 | Beijing | China |
| Site CN86014 | Beijing | China |
| Site CN86010 | Chengdu | China |
| Site CN86009 | Guangzhou | China |
| Site CN86018 | Guangzhou | China |
| Site CN86003 | Lanzhou | China |
| Site CN86013 | Shanghai | China |
| Site CN86002 | Suzhou | China |
| Site CN86021 | Taiyuan | China |
| Site CN86011 | Wuhan | China |
| Site CN86022 | Wuxi | China |
| Site CN86012 | Xi'an | China |
| Site CN86007 | Zhengzhou | China |
| Lack of Efficacy |
|
| Adverse Event |
|
| Miscellaneous |
|
Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Mean Number of Micturitions per 24 hours | Full Analysis Set included all participants who were randomized and received at least 1 dose of investigational product (IP) and had at least 1 post baseline measurement for mean number of micturitions per 24 hours. Participants with available data were analyzed. | Mean | Standard Deviation | micturitions per 24 hours |
|
|
|
|
| Secondary | Number of Participants With Treatment Emergent Adverse Events | AE was defined as any untoward medical occurrence in a participant administered a study drug or had undergone study procedures and which did not necessarily have had a causal relationship with the treatment. An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, Electrocardiography (ECG) data, and physical exam) was defined as an AE only if the abnormality induced clinical signs or symptoms or requires active intervention or requires interruption or discontinuation of study medication or the abnormality or investigational value was clinically significant in the opinion of the investigator. Treatment emergent AE was defined as an AE observed after starting administration of the IP and 30 days after the final administration of study drug. | Safety Analysis Set (SAF) consisted of all participants who took at least 1 dose of IP. | Posted | Number | participants | From first dose up to 30 days after last dose (up to week 16) |
|
|
|
| Secondary | Change From Baseline to Week 12 in Post Void Residual (PVR) Volume | PVR was assessed by ultrasonography. | SAF population with available data at specified time point. | Posted | Mean | Standard Deviation | milliliter | Baseline, week 12 |
|
|
|
| Secondary | Change From Baseline in Mean Number of Grade 3 or 4 Patient Perception of Intensity of Urgency Scale (PPIUS) Urgency Episodes Per 24 Hours | Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which was difficult to defer. An urgency episode was defined as any micturition or incontinence episode with a severity of grade 3 or 4, assessed by participants based on the PPIUS, where grade 0 = No urgency; grade 1 = Mild urgency; grade 2 = Moderate urgency, could delay voiding a short while; grade 3 = Severe urgency, could not delay voiding; grade 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per day was calculated as the average number of times a participant recorded an urgency episode (grade 3 and/or 4) with or without incontinence per day during the 3-day micturition diary period. | FAS population with available data at specified time point. | Posted | Mean | Standard Deviation | urgency episodes per 24 hours | Baseline and weeks 4, 8, and 12 |
|
|
|
|
| Secondary | Change From Baseline in Mean Number of Daytime Incontinence Episodes Per 24 Hours | An incontinence episode was defined as an episode with any involuntary loss of urine. Daytime was defined as time between waking up in the morning and going to sleep later the same day or next day. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and at various specified time-intervals. | FAS population with available data at specified time point. | Posted | Mean | Standard Deviation | incontinence episodes per 24 hours | Baseline and weeks 4, 8, and 12 |
|
|
|
|
| Secondary | Change From Baseline in Mean Number of Nighttime Incontinence Episodes Per 24 Hours | An incontinence episode was defined as an episode with any involuntary loss of urine. Nightime was defined as time between between going to sleep on a day and waking up on the same or next day. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and at various specified time-intervals. | FAS population with available data at specified time point. | Posted | Mean | Standard Deviation | incontinence episodes per 24 hours | Baseline and weeks 4, 8, and 12 |
|
|
|
|
| Secondary | Change From Baseline in Mean Number of Urge Incontinence Episodes Per 24 Hours | An incontinence episode was defined as an episode with any involuntary loss of urine. The mean number of urge incontinence episodes per 24 hours was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and at various specified time-intervals. | FAS population with available data at specified time point. | Posted | Mean | Standard Deviation | urge incontinence episodes per 24 hours | Baseline and weeks 4, 8, and 12 |
|
|
|
|
| Secondary | Change From Baseline in OAB Symptom Score (OABSS) | The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms: Daytime Frequency ("How many times do you typically urinate from waking in the morning until sleeping at night?" where scores range from 0-2), Nighttime Frequency ("How many times do you typically wake up to urinate from sleeping at night until waking in the morning?" where scores range from 0-3), Urgency ("How often do you have a sudden desire to urinate, which is difficult to defer?" where scores range from 0-5), Urgency Incontinence ("How often do you leak urine because you cannot defer the sudden desire to urinate?" where scores range from 0-5). The total score ranges from 0 to 15 with higher score indicating more symptoms. | FAS population with available data at specified time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and weeks 4, 8, and 12 |
|
|
|
|
| Secondary | Change From Baseline in Mean Number of Micturition Per 24 Hours | A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period. | FAS population with available data at specified time point. | Posted | Mean | Standard Deviation | micturitions per 24 hours | Baseline and weeks 4 and 8 |
|
|
|
|
| 0 |
| 44 |
| 3 |
| 44 |
| 1 |
| 44 |
| EG001 | Mirabegron 25 mg (Later Up-titrated to 50 mg) | Participants received single oral dose of mirabegron 25 mg tablet once daily, at the same time after a meal until week 4 or 8 and were up-titrated to receive Mirabegron 50 mg until week 12. | 0 | 39 | 1 | 39 | 0 | 39 |
| EG002 | Mirabegron 50 mg (Up-titrated From 25 mg) | Participants who were up-titrated from mirabegron 25 mg received single oral dose of Mirabegron 50 mg tablet once daily, at the same time after a meal from week 4 or 8 until week 12. | 0 | 39 | 2 | 39 | 3 | 39 |
| EG003 | Mirabegron 50 mg | Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks. | 0 | 165 | 8 | 165 | 6 | 165 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA v23.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
|
| Electrocardiogram ST segment abnormal | Investigations | MedDRA v23.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
|
| Cerebrovascular insufficiency | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
|
| Cystitis interstitial | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
|
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA v23.0 | Systematic Assessment |
|
| Uterine polyp | Reproductive system and breast disorders | MedDRA v23.0 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v23.0 | Systematic Assessment |
|
| Abortion induced | Surgical and medical procedures | MedDRA v23.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
|
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Change at Week 8 |
|
|
| Change at Week 12 |
|
|
| Week 4 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate. | LS Mean | -2.47 | Standard Error of the Mean | 0.23 | 2-Sided | 95 | -2.93 | -2.02 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 8 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate. | LS Mean | -3.13 | Standard Error of the Mean | 0.42 | 2-Sided | 95 | -3.96 | -2.30 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 8 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate. | LS Mean | -2.93 | Standard Error of the Mean | 0.23 | 2-Sided | 95 | -3.39 | -2.47 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 12 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate. | LS Mean | -3.47 | Standard Error of the Mean | 0.46 | 2-Sided | 95 | -4.37 | -2.56 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 12 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate. | LS Mean | -3.59 | Standard Error of the Mean | 0.24 | 2-Sided | 95 | -4.06 | -3.12 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Change at Week 8 |
|
|
| Change at Week 12 |
|
|
| Week 4 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate. | LS Mean | -0.81 | Standard Error of the Mean | 0.08 | 2-Sided | 95 | -0.97 | -0.65 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 8 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate. | LS Mean | -0.88 | Standard Error of the Mean | 0.15 | 2-Sided | 95 | -1.17 | -0.58 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 8 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate. | LS Mean | -0.94 | Standard Error of the Mean | 0.08 | 2-Sided | 95 | -1.10 | -0.78 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 12 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate. | LS Mean | -1.03 | Standard Error of the Mean | 0.16 | 2-Sided | 95 | -1.35 | -0.71 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 12 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate. | LS Mean | -0.98 | Standard Error of the Mean | 0.09 | 2-Sided | 95 | -1.14 | -0.81 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Change at Week 8 |
|
|
| Change at Week 12 |
|
|
| Week 4 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate. | LS Mean | -0.46 | Standard Error of the Mean | 0.04 | 2-Sided | 95 | -0.53 | -0.38 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 8 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate. | LS Mean | -0.53 | Standard Error of the Mean | 0.07 | 2-Sided | 95 | -0.67 | -0.39 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 8 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate. | LS Mean | -0.45 | Standard Error of the Mean | 0.04 | 2-Sided | 95 | -0.52 | -0.37 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 12 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate. | LS Mean | -0.53 | Standard Error of the Mean | 0.08 | 2-Sided | 95 | -0.68 | -0.38 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 12 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate. | LS Mean | -0.52 | Standard Error of the Mean | 0.04 | 2-Sided | 95 | -0.60 | -0.45 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Change at Week 8 |
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| Change at Week 12 |
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| Week 4 | MMRM | <0.001 | RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate. | LS Mean | -1.11 | Standard Error of the Mean | 0.07 | 2-Sided | 95 | -1.25 | -0.96 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 8 | MMRM | <0.001 | RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate. | LS Mean | -1.26 | Standard Error of the Mean | 0.14 | 2-Sided | 95 | -1.53 | -0.99 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 8 | MMRM | <0.001 | RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate. | LS Mean | -1.20 | Standard Error of the Mean | 0.07 | 2-Sided | 95 | -1.34 | -1.05 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 12 | MMRM | <0.001 | RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate. | LS Mean | -1.25 | Standard Error of the Mean | 0.15 | 2-Sided | 95 | -1.54 | -0.96 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 12 | MMRM | <0.001 | RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate. | LS Mean | -1.27 | Standard Error of the Mean | 0.08 | 2-Sided | 95 | -1.42 | -1.12 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Change at Week 8 |
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| Change at Week 12 |
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| Week 4 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate. | LS Mean | -3.05 | Standard Error of the Mean | 0.20 | 2-Sided | 95 | -3.44 | -2.65 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 8 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate. | LS Mean | -5.09 | Standard Error of the Mean | 0.36 | 2-Sided | 95 | -5.80 | -4.39 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 8 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate. | LS Mean | -4.30 | Standard Error of the Mean | 0.20 | 2-Sided | 95 | -4.70 | -3.90 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 12 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate. | LS Mean | -6.01 | Standard Error of the Mean | 0.39 | 2-Sided | 95 | -6.78 | -5.24 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 12 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate. | LS Mean | -5.40 | Standard Error of the Mean | 0.21 | 2-Sided | 95 | -5.82 | -4.98 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Change at Week 8 |
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| Week 4 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate. | LS Mean | -2.36 | Standard Error of the Mean | 0.28 | 2-Sided | 95 | -2.90 | -1.81 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 8 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate. | LS Mean | -3.20 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | -4.20 | -2.20 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |
| Week 8 | MMRM | <0.001 | RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate. | LS Mean | -2.92 | Standard Error of the Mean | 0.28 | 2-Sided | 95 | -3.47 | -2.37 | Superiority | Statistical testing was conducted using 2-sided at a significance level of 0.05. |