Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001212-20 | EudraCT Number | EudraCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component.
This is an open-label extension study following the double blind 905-CL-055 study
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Group | Experimental | Participants who received at least one dose of open-label fixed dose combination (FDC) treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg) | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Safety is monitored by collecting AEs, which include abnormal lab parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A serious AE (SAE) was an AE resulting in death, persistent or significant disability/incapacity or congenital anomaly/birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity (mild-no disruption of normal daily activities, moderate-affected normal daily activities or severe-inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after the intake of first dose of double-blind study drug (if on FDC in 905-CL-055) or after first open-label dose until 30 days after the last dose of open-label study drug (in 905-CL-057). | From first dose of double-blind study drug (if on FDC in 905-CL-055) or first open-label dose up to 30 days after last dose of open-label study drug (in 905-CL-057) (up to 56 weeks) |
| Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume | PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan. | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) | Qmax during a micturition (urination) was recorded using uroflowmetry. | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in Average Flow Rate (Qmean) | Qmean during a micturition (urination) was recorded using uroflowmetry. | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | Baseline and up to 52 weeks of FDC treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Global Development | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innsbruck | 6020 | Austria | ||||
Not provided
| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results website | View source |
Not provided
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.
All eligible participants started with 4 weeks of open-label FDC 0.4 mg/6 mg and were given the opportunity to adjust their dose at 3 monthly intervals thereafter if desired.
Participants were eligible for Study 905-CL-057 if they completed 12 weeks of double-blind treatment in Study 905-CL-055, complied with inclusion criteria and did not meet any exclusion criteria. Participants treated with the FDC 0.4 mg/6 mg or 0.4 mg/9 mg for maximally 40 weeks.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Total Group | Participants who received at least one dose of open-label FDC treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg) | Drug | oral |
|
|
The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: • Incomplete emptying of the bladder • Intermittency • Weak stream • Hesitancy • Frequency • Urgency • Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic). |
| Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS]) | The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale: • 0. No urgency; • 1. Mild urgency; • 2. Moderate urgency; • 3. Severe urgency; • 4. Urgency incontinence TUS/TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency. | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition | A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition | A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours | An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours | An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours | A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours | The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in IPSS Voiding Score | The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic). | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in IPSS Storage Score | The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on 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 storage questions (frequency,urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic). | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score | The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible). | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in Individual IPSS Scores | The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: • Incomplete emptying of the bladder • Intermittency • Weak stream • Hesitancy • Frequency • Urgency • Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in Symptom Bother Score | The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6.The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement. | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Coping Score | The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Concern Score | The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Sleep Score | The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Social Score | The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Total Score | The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. | Baseline and up to 52 weeks of FDC treatment |
| Number of OAB-q Responders Based on Health-related Quality of Life: Total Score | A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10. | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in EQ-5D Mobility Score | The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed). | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in EQ-5D Self-care Score | The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress). | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in EQ-5D Usual Activities Score | The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities). | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score | The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain). | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score | The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious). | Baseline and up to 52 weeks of FDC treatment |
| Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score | Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state). | Baseline and up to 52 weeks of FDC treatment |
| Vienna |
| 1090 |
| Austria |
| Minsk | 220036 | Belarus |
| Minsk | 220119 | Belarus |
| Minsk | 223040 | Belarus |
| Antwerp | 2020 | Belgium |
| Edegem | 2650 | Belgium |
| Ghent | 9000 | Belgium |
| Leuven | 3000 | Belgium |
| Liège | 4000 | Belgium |
| Hradec Králové | 500 02 | Czechia |
| Ostrava | 700 30 | Czechia |
| Pilsen | 301 24 | Czechia |
| Roudnice nad Labem | 413 01 | Czechia |
| Uherské Hradiště | 686 08 | Czechia |
| Ústí nad Labem | 400 01 | Czechia |
| Zd'ar Nad Sazavou | 591 01 | Czechia |
| Colmar | 68024 | France |
| Montluçon | 03100 | France |
| Orléans | 45067 | France |
| Paris | 75010 | France |
| Paris | 75020 | France |
| Pierre-Bénite | 69495 | France |
| Bautzen | 02625 | Germany |
| Eisleben Lutherstadt | 06295 | Germany |
| Frankfurt | 65933 | Germany |
| Ganderkesee | 27777 | Germany |
| Hagenow | 19230 | Germany |
| Halle | 06132 | Germany |
| Hamburg | 20253 | Germany |
| Henningsdorf | 16761 | Germany |
| Hettstedt | 06333 | Germany |
| Koblenz | 56068 | Germany |
| Leipzig | 04105 | Germany |
| Leipzig | 04109 | Germany |
| Neustadt in Sachsen | 01844 | Germany |
| Radebeul | 01445 | Germany |
| Sachsen | 06526 | Germany |
| Trier | 54290 | Germany |
| Uetersen | 25436 | Germany |
| Avellino | 83100 | Italy |
| Catanzaro | 88100 | Italy |
| Palermo | 90146 | Italy |
| Treviglio | 24047 | Italy |
| Amsterdam | 100 AD | Netherlands |
| Apeldoorn | 7334 DZ | Netherlands |
| Doetinchem | 7009 BL | Netherlands |
| Maastricht | 6229 HX | Netherlands |
| Sneek | 8600 BA | Netherlands |
| Tilburg | 5022 GC | Netherlands |
| Winterswijk | 7101 BN | Netherlands |
| Bielsko-Biala | 43-300 | Poland |
| Bydgoszcz | 85-094 | Poland |
| Krakow | 31-530 | Poland |
| Puławy | 24-100 | Poland |
| Warsaw | 02-005 | Poland |
| Więcbork | 89-410 | Poland |
| Nitra | 949 01 | Slovakia |
| Piešťany | 921 02 | Slovakia |
| Prešov | 080 01 | Slovakia |
| Skalica | 909 82 | Slovakia |
| Trenčín | 911 01 | Slovakia |
| Cardiff | CF14 5GJ | United Kingdom |
| Chorley | PR7 7NA | United Kingdom |
| Liverpool | L22 0LG | United Kingdom |
| Northwood | HA6 2RN | United Kingdom |
| Oxford | OX3 7LJ | United Kingdom |
| Reading | RG2 7AG | United Kingdom |
| Sheffield | S10 2JF | United Kingdom |
| Taunton | TA1 5DA | United Kingdom |
| Safety Analysis Set (SAF) |
|
| Full Analysis Set (FAS) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
SAF and FAS (study-specific)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Total Group | Participants who received at least one dose of open-label FDC treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Sex/Gender, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Total International Prostate Symptom Score (IPSS) | FAS population excluding 5 patients with invalid questionnaires. The IPSS is a validated global questionnaire to assess the degree of "bother" from urinary symptoms, based on answers to 7questions concerning urinary symptoms: • Incomplete emptying of the bladder • Intermittency • Weak stream • Hesitancy • Frequency • Urgency • Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||||||||||
| Total International Prostate Symptom Score (IPSS) voiding score | FAS population excluding 5 patients with invalid questionnaires. The IPSS is a validated global questionnaire to assess the degree of "bother" from urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||||||||||
| Total International Prostate Symptom Score (IPSS) storage score | FAS population excluding 5 patients with invalid questionnaires.The IPSS is a validated global questionnaire to assess the degree of "bother" from urinary symptoms based on answers to 7 questions. 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 storage questions (frequency, urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||||||||||
| IPSS Quality of Life Score(Qol) score | FAS population excluding 5 patients with invalid questionnaires. The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||||||||||
| Total Urgency Frequency Score (TUFS) (previous known as Total Urgency Score (TUS) | FAS population.The Participant Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale: 0.No urgency; 1.Mild urgency; 2.Moderate urgency; 3.Severe urgency; 4.Urgency incontinence. TUFS/TUS was the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||||||||||
| Micturitions/24 hour | FAS population. A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | Mean | Standard Deviation | micturitions |
| ||||||||||||||||||||||||
| Volume voided/micturition | FAS population. A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | Mean | Standard Deviation | ml |
| ||||||||||||||||||||||||
| Incontinence episodes/24 hour | FAS population. An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | Mean | Standard Deviation | incontinence episodes |
| ||||||||||||||||||||||||
| Urgency incontinence episodes /24 hour | FAS population. An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | Mean | Standard Deviation | urgency incontinence episodes |
| ||||||||||||||||||||||||
| Nocturia episodes/ 24 hour | FAS population. A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | Mean | Standard Deviation | nocturia episodes |
|
| 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 | Number of Participants With Adverse Events (AEs) | Safety is monitored by collecting AEs, which include abnormal lab parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A serious AE (SAE) was an AE resulting in death, persistent or significant disability/incapacity or congenital anomaly/birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity (mild-no disruption of normal daily activities, moderate-affected normal daily activities or severe-inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after the intake of first dose of double-blind study drug (if on FDC in 905-CL-055) or after first open-label dose until 30 days after the last dose of open-label study drug (in 905-CL-057). | Safety analysis set-participants who received at least 1 dose of the FDC tamsulosin/solifenacin 0.4 mg/6 mg or 0.4 mg/9 mg during the open-label treatment period and had any data reported after the first dose of the FDC during the open-label treatment period | Posted | Number | participants | From first dose of double-blind study drug (if on FDC in 905-CL-055) or first open-label dose up to 30 days after last dose of open-label study drug (in 905-CL-057) (up to 56 weeks) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume | PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan. | SAF population with at least one baseline and one post-baseline PVR volume measured. | Posted | Mean | Standard Deviation | ml | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) | Qmax during a micturition (urination) was recorded using uroflowmetry. | SAF population with at least one baseine and one post-baseline micturition episode. | Posted | Mean | Standard Deviation | ml/s | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline to End of Treatment in Average Flow Rate (Qmean) | Qmean during a micturition (urination) was recorded using uroflowmetry. | SAF population with at least one baseline and one post-baseline micturition episode. | Posted | Mean | Standard Deviation | ml/s | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS) | The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: • Incomplete emptying of the bladder • Intermittency • Weak stream • Hesitancy • Frequency • Urgency • Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic). | Full Analysis Set (FAS)-participants who took at least 1 dose of the FDC during the open-label study, had a total IPSS or TUS at baseline and had at least one total IPSS or TUS after first dose of the FDC in Study 905-CL-057. Excluded 5 participants with invalid questionnaires. Last Observation Carried Forward (LOCF) imputation was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | FAS population with data available at both baseline and end of treatment. LOCF imputation was used. | Posted | Mean | Standard Deviation | micturitions | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition | A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | FAS population with data available at both baseline and end of treatment. LOCF imputation was used. | Posted | Mean | Standard Deviation | ml | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition | A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | FAS population with data available at both baseline and end of treatment. LOCF imputation was used. | Posted | Mean | Standard Deviation | ml | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours | An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | FAS population with at least 1 urgency episode at baseline. LOCF imputation was used. | Posted | Mean | Standard Deviation | urgency episodes | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours | An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | FAS population and at least 1 urgency incontinence episode at baseline. LOCF imputation was used. | Posted | Mean | Standard Deviation | urgency incontinence episodes | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | FAS population and at least 1 incontinence episode at baseline. LOCF imputation was used. | Posted | Mean | Standard Deviation | incontinence episodes | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours | A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | FAS population and at least 1 nocturia episode at baseline. LOCF imputation was used. | Posted | Mean | Standard Deviation | nocturia episodes | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours | The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. | FAS population and at least 1 use of a pad at baseline. LOCF imputation was used. | Posted | Mean | Standard Deviation | pads | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS]) | The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale: • 0. No urgency; • 1. Mild urgency; • 2. Moderate urgency; • 3. Severe urgency; • 4. Urgency incontinence TUS/TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency. | FAS population with data available at both baseline and end of treatment. LOCF imputation was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in IPSS Voiding Score | The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic). | A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in IPSS Storage Score | The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on 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 storage questions (frequency,urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic). | A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score | The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible). | FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used | Posted | Mean | Standard Deviation | units on a scale | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in Individual IPSS Scores | The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: • Incomplete emptying of the bladder • Intermittency • Weak stream • Hesitancy • Frequency • Urgency • Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. | A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in Symptom Bother Score | The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6.The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement. | FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used | Posted | Mean | Standard Deviation | units on a scale | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Coping Score | The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. | FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used | Posted | Mean | Standard Deviation | units on a scale | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Concern Score | The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. | FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used | Posted | Mean | Standard Deviation | units on a scale | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Sleep Score | The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. | FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used | Posted | Mean | Standard Deviation | units on a scale | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Social Score | The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. | FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used | Posted | Mean | Standard Deviation | units on a scale | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Total Score | The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. | FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used | Posted | Mean | Standard Deviation | units on a scale | Baseline and up to 52 weeks of FDC treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of OAB-q Responders Based on Health-related Quality of Life: Total Score | A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10. | FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used | Posted | Number | percentage of participants | Baseline and up to 52 weeks of FDC treatment |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in EQ-5D Mobility Score | The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed). | FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used | Posted | Number | participants | Baseline and up to 52 weeks of FDC treatment |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in EQ-5D Self-care Score | The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress). | FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used | Posted | Number | participants | Baseline and up to 52 weeks of FDC treatment |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in EQ-5D Usual Activities Score | The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities). | FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used | Posted | Number | participants | Baseline and up to 52 weeks of FDC treatment |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score | The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain). | FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used | Posted | Number | participants | Baseline and up to 52 weeks of FDC treatment |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score | The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious). | FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used | Posted | Number | participants | Baseline and up to 52 weeks of FDC treatment |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score | Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state). | FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used | Posted | Mean | Standard Deviation | units on a scale | Baseline and up to 52 weeks of FDC treatment |
|
|
From first dose of double-blind study drug (if on FDC in 905-CL-055) or first open-label dose up to 30 days after last dose of open-label study drug (in 905-CL-057) (up to 56 weeks)
Not provided
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 Group | Participants who received at least one dose of open-label FDC treatment | 64 | 1,066 | 180 | 1,066 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Malignant peritoneal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Neuroendocrine tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Prostatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Atrial fibillation | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cerebral disorder | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Lateral medullary syndrome | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Post procedural haematuria | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Bronchietasis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Lobar pnemonia | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Femoral arterial stenosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Iliac artery occulsion | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Macular degeneration | Eye disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA (12.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Institute and/or Principle 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 at least 90 days prior to publication for review and comment. Sponsor may delay the publication to seek patent approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Global Medical Science | Astellas Pharma Europe B.V. | astellas.resultsdisclosure@astellas.com |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Asian |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| Any TEAE causing discontinuation of study drug. |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|