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| ID | Type | Description | Link |
|---|---|---|---|
| A0221006 |
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To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fesoterodine fumarate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fesoterodine fumarate | Drug | 4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | The number of subjects who experienced AEs (all causality and treatment-related ) based on safety assessment during the study were summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized. | 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | The number of UUI episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of UUI episodes per 24 hours was calculated as the total number of UUI episodes for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Inegeku, Chibashi | Chiba | Japan | |||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
After screening, eligible subjects entered a run-in phase during which they completed a 3-day micturition diary for 3 consecutive days in 7 days prior to Baseline visit. At Baseline visit, the diary data and screening laboratory data were checked against the entry criteria to identify subjects eligible for study participation.
Subjects were screened at 12 centers in Japan.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Total | All subjects |
| FG001 | 4 mg | Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg) |
| FG002 | 4 mg > 8 mg > 4 mg | Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg) |
| FG003 | 4 mg > 8 mg | Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 4 mg | Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg) |
| BG001 | 4 mg > 8 mg > 4 mg | Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 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 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | The number of UUI episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of UUI episodes per 24 hours was calculated as the total number of UUI episodes for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline | Of the efficacy analysis set, the subjects whose mean number of UUI episodes per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using last observation carried forward (LOCF) were analyzed. (n=number of analyzable subjects) | Posted | Mean | Standard Deviation | Number of episodes | Week 4, 8, 28 and 52 |
|
52 Weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total | All subjects |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
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| ID | Term |
|---|---|
| C526675 | fesoterodine |
Not provided
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| Week 4, 8, 28 and 52 |
| Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | The number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of micturitions per 24 hours was calculated as the total number of micturitions for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline | Week 4, 8, 28 and 52 |
| Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | The number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of urgency episodes per 24 hours was calculated as the total number of urgency episodes for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline | Week 4, 8, 28 and 52 |
| Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | The number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of incontinence episodes per 24 hours was calculated as the total number of incontinence episodes for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline | Week 4, 8, 28 and 52 |
| Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | The number of nighttime micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of nighttime micturitions per 24 hours was calculated as the total number of nighttime micturitions for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline | Week 4, 8, 28 and 52 |
| Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean voided volume per micturitions was calculated as the total voided volume for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline | Week 4, 8, 28 and 52 |
| Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | KHQ was used to assess the impact of bladder problems on quality of life. The scores ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. A negative change indicates improvement. KHQ consists of the following domains:
Change: mean at Week 28 and 52 minus mean at Baseline | Week 28 and 52 |
| Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | OAB-q was used to assess the extent of subjects who had been botehred by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). OAB-q consists of the symptom bother score(SBS), the HRQL total score and subscale scores (Coping, Concern, Sleep and Social). The SBS ranges from 0 to 100, where 0=minimal severity and 100=greatest severity (negative change indicates improvement). The HRQL scores range from 0 to 100, where 0=worst outcome and 100=best outcome (positive change indicates improvement). Change: mean at Week 28 and 52 minus mean at baseline | Week 28 and 52 |
| The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage | The number of subjects whose perception of bladder condition improved at least by one grade on PPBC from baseline at Week 28 and 52. The PPBC was rated on a 6-point scale as follows:
| Week 28 and 52 |
| Change From Baseline in Grade of PPBC at Week 28 and 52 | The PPBC assessment was rated on a 6-point scale as follows:
Change: mean at Week 28 and 52 minus mean at baseline A negative change indicates improvement. | Week 28 and 52 |
| Akashi-shi |
| Hyōgo |
| Japan |
| Pfizer Investigational Site | Amagasaki-shi | Hyōgo | Japan |
| Pfizer Investigational Site | Chuou-ku, Koube-shi | Hyōgo | Japan |
| Pfizer Investigational Site | Kaibara-cho, Tanba-shi | Hyōgo | Japan |
| Pfizer Investigational Site | Nishinomiya-shi | Hyōgo | Japan |
| Pfizer Investigational Site | Kawasakishi | Kanagawa | Japan |
| Pfizer Investigational Site | Sagamihara-shi | Kanagawa | Japan |
| Pfizer Investigational Site | Nara | Nara | Japan |
| Pfizer Investigational Site | Osaka | Osaka | Japan |
| Pfizer Investigational Site | Edogawa-ku | Tokyo | Japan |
| Pfizer Investigational Site | Shibuya-ku | Tokyo | Japan |
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Protocol Violation |
|
| Pregnancy |
|
| BG002 | 4 mg > 8 mg | Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
All subjects |
| OG001 | 4 mg | Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg) |
| OG002 | 4 mg > 8 mg > 4 mg | Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg) |
| OG003 | 4 mg > 8 mg | Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained) |
|
|
| Secondary | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | The number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of micturitions per 24 hours was calculated as the total number of micturitions for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline | The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of anlyzable subjects) | Posted | Mean | Standard Deviation | Number of micturitions | Week 4, 8, 28 and 52 |
|
|
|
| Secondary | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | The number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of urgency episodes per 24 hours was calculated as the total number of urgency episodes for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline | The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of analyzable subjects) | Posted | Mean | Standard Deviation | Number of episodes | Week 4, 8, 28 and 52 |
|
|
|
| Secondary | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | The number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of incontinence episodes per 24 hours was calculated as the total number of incontinence episodes for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline | Of the efficacy analysis set, the subjects whose mean number of incontinence episodes per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n= number of analyzable subjects) | Posted | Mean | Standard Deviation | Number of episodes | Week 4, 8, 28 and 52 |
|
|
|
| Secondary | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | The number of nighttime micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of nighttime micturitions per 24 hours was calculated as the total number of nighttime micturitions for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline | Of the efficacy analysis set, the subjects whose mean number of nighttime micturitions per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of analyzable subjects) | Posted | Mean | Standard Deviation | Number of micturitions | Week 4, 8, 28 and 52 |
|
|
|
| Secondary | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean voided volume per micturitions was calculated as the total voided volume for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline | The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were analyzed. (n=number of analyzable subjects) | Posted | Mean | Standard Deviation | mL | Week 4, 8, 28 and 52 |
|
|
|
| Secondary | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | KHQ was used to assess the impact of bladder problems on quality of life. The scores ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. A negative change indicates improvement. KHQ consists of the following domains:
Change: mean at Week 28 and 52 minus mean at Baseline | The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=number of analyzable subjects) | Posted | Mean | Standard Deviation | Scores on a ascle | Week 28 and 52 |
|
|
|
| Secondary | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | OAB-q was used to assess the extent of subjects who had been botehred by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). OAB-q consists of the symptom bother score(SBS), the HRQL total score and subscale scores (Coping, Concern, Sleep and Social). The SBS ranges from 0 to 100, where 0=minimal severity and 100=greatest severity (negative change indicates improvement). The HRQL scores range from 0 to 100, where 0=worst outcome and 100=best outcome (positive change indicates improvement). Change: mean at Week 28 and 52 minus mean at baseline | The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=analyzable subjects) | Posted | Mean | Standard Deviation | Scores on a scale | Week 28 and 52 |
|
|
|
| Secondary | The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage | The number of subjects whose perception of bladder condition improved at least by one grade on PPBC from baseline at Week 28 and 52. The PPBC was rated on a 6-point scale as follows:
| The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=number of analyzable subjects) | Posted | Number | Number of subjects | Week 28 and 52 |
|
|
|
| Secondary | Change From Baseline in Grade of PPBC at Week 28 and 52 | The PPBC assessment was rated on a 6-point scale as follows:
Change: mean at Week 28 and 52 minus mean at baseline A negative change indicates improvement. | The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=analyzable subjects) | Posted | Mean | Standard Deviation | Scores on a scale | Week 28 and 52 |
|
|
|
| Primary | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | The number of subjects who experienced AEs (all causality and treatment-related ) based on safety assessment during the study were summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized. | The safety analysis set (all subjects who took at least one dose of study drug) was analyzed. | Posted | Number | Number of subjects | 52 Weeks |
|
|
|
| 1 |
| 152 |
| 138 |
| 152 |
| EG001 | 4 mg | Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg) | 1 | 99 | 91 | 99 |
| EG002 | 4 mg > 8 mg > 4 mg | Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg) | 0 | 25 | 25 | 25 |
| EG003 | 4 mg > 8 mg | Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained) | 0 | 28 | 22 | 28 |
| Vision blurred | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Residual urine | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Urine flow decreased | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| 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 |
| Week 4 (n=150, 97, 25, 28) |
|
| Week 8 (n=148, 95, 25, 28) |
|
| Week 28 (n=137, 87, 23, 27) |
|
| Week 52 (n=133, 84, 22, 27) |
|
| Week 52 (LOCF) (n=150, 97, 25, 28) |
|
| Week 4 (n=150, 97, 25, 28) |
|
| Week 8 (n=148, 95, 25, 28) |
|
| Week 28 (n=137, 87, 23, 27) |
|
| Week 52 (n=133, 84, 22, 27) |
|
| Week 52 (LOCF) (n=150, 97, 25, 28) |
|
| Week 4 (n=103, 62, 17,24) |
|
| Week 8 (n=102, 61, 17, 24) |
|
| Week 28 (n= 97, 58, 16, 23) |
|
| Week 52 (n=94, 56, 15, 23) |
|
| Week 52 (LOCF) (n=103, 62, 17,24) |
|
| Week 4 (n=116, 69, 23, 24) |
|
| Week 8 (n=115, 68, 23, 24) |
|
| Week 28 (n=106, 62, 21, 23) |
|
| Week 52 (n=103, 60, 20, 23) |
|
| Week 52 (LOCF) (n=116, 69, 23, 24) |
|
| Week 4 (n=150, 97, 25, 28) |
|
| Week 8 (n=148, 95, 25, 28) |
|
| Week 28 (n=137, 87, 23, 27) |
|
| Week 52 (n=133, 84, 22, 27) |
|
| Week 52 (LOCF) (n=150, 97, 25, 28) |
|
| GHP: Week 28 (n=137, 87, 23, 27) |
|
| GHP: Week 52 (n=134, 85, 22, 27) |
|
| Impact on life: Baseline (n=150, 97, 25, 28) |
|
| Impact on life: Week 28 (n=137, 87, 23, 27) |
|
| Impact on life: Week 52 (n=134, 85, 22, 27) |
|
| Role limitations: Baseline (n=150, 97, 25, 28) |
|
| Role limitations: Week 28 (n=137, 87, 23, 27) |
|
| Role limitations: Week 52 (n=134, 85, 22, 27) |
|
| Physical limitations: Baseline (n=150, 97, 25, 28 |
|
| Physical limitations: Week 28 (n=137, 87, 23, 27) |
|
| Physical limitations: Week 52 (n=134, 85, 22, 27) |
|
| Social limitations: Baseline (n=150, 97, 25, 28) |
|
| Social limitations: Week 28 (n=137, 87, 23, 27) |
|
| Social limitations: Week 52 (n=134, 85, 22, 27) |
|
| PR: Baseline (n=124, 82, 18, 24) |
|
| PR: Week 28 (n=110, 71, 16, 23) |
|
| PR: Week 52 (n=109, 70, 16, 23) |
|
| Emotions: Baseline (n=150, 97, 25, 28) |
|
| Emotions: Week 28 (n=137, 87, 23, 27) |
|
| Emotions: Week 52 (n=134, 85, 22, 27) |
|
| Sleep/energy: Baseline (n=150, 97, 25, 28) |
|
| Sleep/energy: Week 28 (n=137, 87, 23, 27) |
|
| Sleep/energy: Week 52 (n=134, 85, 22, 27) |
|
| ISM: Baseline (n=150, 97, 25, 28) |
|
| ISM: Week 28 (n=137, 87, 23, 27) |
|
| ISM: Week 52 (n=134, 85, 22, 27) |
|
| SBS: Week 28 (n=137, 87, 23, 27) |
|
| SBS: Week 52 (n=134, 85, 22, 27) |
|
| HRQL-Total: Baseline (n=150, 97, 25, 28) |
|
| HRQL-Total: Week 28 (n=137, 87, 23, 27) |
|
| HRQL-Total: Week 52 (n=134, 85, 22, 27) |
|
| HRQL-Coping: Baseline (n=150, 97, 25, 28) |
|
| HRQL-Coping: Week 28 (n=137, 87, 23, 27) |
|
| HRQL-Coping: Week 52 (n=134, 85, 22, 27) |
|
| HRQL-Concern: Baseline (n=150, 97, 25, 28) |
|
| HRQL-Concern: Week 28 (n=137, 87, 23, 27) |
|
| HRQL-Concern: Week 52 (n=134, 85, 22, 27) |
|
| HRQL-Sleep: Baseline (n=150, 97, 25, 28) |
|
| HRQL-Sleep: Week 28 (n=137, 87, 23, 27) |
|
| HRQL-Sleep: Week 52 (n=134, 85, 22, 27) |
|
| HRQL-Social: Baseline (n=150, 97, 25, 28) |
|
| HRQ- Social: Week 28 (n=137, 87, 23, 27) |
|
| HRQL-Social: Week 52 (n=134, 85, 22, 27) |
|
| Week 52 (n=134, 85, 22, 27) |
|
| Week 28 (n=137, 87, 23, 27) |
|
| Week 52 (n=134, 85, 22, 27) |
|
| Treatment-related AEs |
|
| Serious AEs |
|
| Severe AEs |
|
| Discontinuations due to all-causlity AEs |
|
| Discontinuations due to treatment-related AEs |
|
| DR/TD due to all-causality AEs |
|
| DR/TD due to treatment-related AEs |
|