Overactive Bladder
Conditions
Brief summary
The objective of this study is to determine the problems and questions of safety and efficacy of Toviaz® under the standard conditions of usage.
Detailed description
continuous registration method
Interventions
DRUGToviaz treatment
4 mg starting then can be followed by 8 mg
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who are diagnosed as Overactive Bladder (OAB) defined as urgency, with or without urgency incontinence, usually with frequency and nocturia, in the absence of local or metabolic factors explaining these factors.
Exclusion criteria
* Hypersensitivity to the active substance or to peanut or soya or any of the excipients * Urinary retention * Gastric retention * Uncontrolled narrow angle glaucoma * Myasthenia gravis * Severe hepatic impairment (Child Pugh C) * Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment * Severe ulcerative colitis * Toxic megacolon * Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Toviaz® prolonged-release tablets contain lactose)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug. | An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event was not necessarily had a causal relationship with the treatment or usage. All AEs reported after start of administration of Toviaz were considered as TEAEs. |
| Investigator's Final Assessment of Effectiveness at the End of Study Treatment | At the end of study treatment | The final efficacy assessment included improvement, no change, aggravation, and unevaluable evaluated by the investigator based on the subject's symptoms of frequent micturition, urgency, and urgency urinary incontinence (UUI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Number of Micturitions Per 24 Hours at the End of Study Treatment | Baseline and at the end of study treatment | The number of micturitions per 24 hours was recorded in the case report form (CRF) by the investigator. Baseline was defined as data collected within 1 week prior to the first visit. |
| Change From Baseline in Number of Urgency Episodes Per 24 Hours at the End of Study Treatment | Baseline and at the end of study treatment | The number of urgency episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit. |
| Change From Baseline in Number of UUI Episodes Per 24 Hours at the End of Study Treatment | Baseline and at the end of study treatment | The number of UUI episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit. |
| Participant Perception of Bladder Condition at the End of Study Treatment | Baseline and at the end of study treatment | Participant perception of bladder condition was recorded in the CRF by the investigator. Participants were asked at baseline (BL) and at the end of study treatment (EOT) if the extent to which their bladder condition caused them problems. The possible responses were: No Problem, Very Minor Problems, Minor Problems, Moderate Problems, Severe Problems, or Many Severe Problems. |
| Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | At the end of study treatment | Participants who were assessed as having improved from their baseline condition in the final efficacy assessment were considered as effective. Baseline and treatment characteristics included: geriatric status (\<65 years or ≥65 years), age categories, gender, weight categories, height categories, allergic history, duration of disease, past overactive bladder (OAB) treatment history, medical history, kidney and liver disorders, concomitant medication, total administration period of Toviaz, completion status, daily dose of Toviaz, and long term administration of Toviaz (\<274 days and ≥274 days) . |
Countries
South Korea
Participant flow
Recruitment details
Participants were enrolled between November 2009 and August 2014 from 235 Korean medical care centers.
Participants by arm
| Arm | Count |
|---|---|
| Toviaz Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity. | 3,107 |
| Total | 3,107 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 41 |
| Overall Study | Lack of Efficacy | 64 |
| Overall Study | Other Reasons | 171 |
| Overall Study | Visit Stop | 399 |
Baseline characteristics
| Characteristic | Toviaz |
|---|---|
| Age, Continuous | 60.22 Years STANDARD_DEVIATION 13.98 |
| Sex: Female, Male Female | 1520 Participants |
| Sex: Female, Male Male | 1587 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 219 / 3,107 |
| serious Total, serious adverse events | 0 / 3,107 |
Outcome results
Primary
Investigator's Final Assessment of Effectiveness at the End of Study Treatment
The final efficacy assessment included improvement, no change, aggravation, and unevaluable evaluated by the investigator based on the subject's symptoms of frequent micturition, urgency, and urgency urinary incontinence (UUI).
Time frame: At the end of study treatment
Population: Per-Protocol (PP) Population: participants who had evaluable data and were eligible for the efficacy assessment of the approved indication. The method of last observation carried forward was used in the analysis of effectiveness endpoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Toviaz | Investigator's Final Assessment of Effectiveness at the End of Study Treatment | Improvement | 90.13 Percentage of Participants |
| Toviaz | Investigator's Final Assessment of Effectiveness at the End of Study Treatment | No Change | 9.50 Percentage of Participants |
| Toviaz | Investigator's Final Assessment of Effectiveness at the End of Study Treatment | Aggravation | 0.37 Percentage of Participants |
Primary
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event was not necessarily had a causal relationship with the treatment or usage. All AEs reported after start of administration of Toviaz were considered as TEAEs.
Time frame: From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug.
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Toviaz | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | 8.53 Percentage of Participants |
Secondary
Change From Baseline in Number of Micturitions Per 24 Hours at the End of Study Treatment
The number of micturitions per 24 hours was recorded in the case report form (CRF) by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.
Time frame: Baseline and at the end of study treatment
Population: PP Population; n refers to the number of participants with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Toviaz | Change From Baseline in Number of Micturitions Per 24 Hours at the End of Study Treatment | Baseline (n=2718) | 12.05 Number of Episodes per 24 Hours | Standard Deviation 3.2 |
| Toviaz | Change From Baseline in Number of Micturitions Per 24 Hours at the End of Study Treatment | End of Study Treatment (n=2718) | 8.04 Number of Episodes per 24 Hours | Standard Deviation 2.35 |
| Toviaz | Change From Baseline in Number of Micturitions Per 24 Hours at the End of Study Treatment | Change from Baseline (n=2718) | -4.02 Number of Episodes per 24 Hours | Standard Deviation 2.66 |
p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline in Number of Urgency Episodes Per 24 Hours at the End of Study Treatment
The number of urgency episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.
Time frame: Baseline and at the end of study treatment
Population: PP Population; n refers to the number of participants with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Toviaz | Change From Baseline in Number of Urgency Episodes Per 24 Hours at the End of Study Treatment | Baseline (n=2724) | 3.65 Number of Episodes per 24 Hours | Standard Deviation 3.58 |
| Toviaz | Change From Baseline in Number of Urgency Episodes Per 24 Hours at the End of Study Treatment | End of Study Treatment (n=2724) | 1.27 Number of Episodes per 24 Hours | Standard Deviation 2.05 |
| Toviaz | Change From Baseline in Number of Urgency Episodes Per 24 Hours at the End of Study Treatment | Change from Baseline (n=2724) | -2.37 Number of Episodes per 24 Hours | Standard Deviation 2.67 |
p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline in Number of UUI Episodes Per 24 Hours at the End of Study Treatment
The number of UUI episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.
Time frame: Baseline and at the end of study treatment
Population: PP Population; n refers to the number of participants with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Toviaz | Change From Baseline in Number of UUI Episodes Per 24 Hours at the End of Study Treatment | Baseline (n=2800) | 1.07 Number of Episodes per 24 Hours | Standard Deviation 2.05 |
| Toviaz | Change From Baseline in Number of UUI Episodes Per 24 Hours at the End of Study Treatment | End of study treatment (n=2800) | 0.27 Number of Episodes per 24 Hours | Standard Deviation 0.89 |
| Toviaz | Change From Baseline in Number of UUI Episodes Per 24 Hours at the End of Study Treatment | Change from baseline (n=2800) | -0.80 Number of Episodes per 24 Hours | Standard Deviation 1.65 |
p-value: <0.0001t-test, 2 sided
Secondary
Participant Perception of Bladder Condition at the End of Study Treatment
Participant perception of bladder condition was recorded in the CRF by the investigator. Participants were asked at baseline (BL) and at the end of study treatment (EOT) if the extent to which their bladder condition caused them problems. The possible responses were: No Problem, Very Minor Problems, Minor Problems, Moderate Problems, Severe Problems, or Many Severe Problems.
Time frame: Baseline and at the end of study treatment
Population: PP Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Many Severe Problems/EOT: Severe Problems | 51 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: No Problem/EOT: No problem | 0 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: No Problem/EOT: Very Minor Problems | 0 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: No Problem/EOT: Minor Problems | 0 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: No Problem/EOT: Moderate Problems | 1 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: No Problem/EOT: Severe Problems | 0 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: No Problem/EOT: Many Severe Problems | 0 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Very Minor Problems/EOT:No Problem | 29 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL:Very Minor Problems/EOT: Very Minor Problems | 33 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Very Minor Problems/EOT: Minor Problems | 0 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Very Minor Problems/EOT: Moderate Problems | 0 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Very Minor Problems/EOT: Severe Problems | 0 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Very Minor Problems/EOT: Many Severe Problems | 0 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Minor Problems/EOT: No Problem | 105 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Minor Problems/EOT: Very Minor Problems | 134 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Minor Problems/EOT: Minor Problems | 42 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Minor Problems/EOT:Moderate Problems | 1 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Minor Problems/EOT: Severe Problems | 0 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Minor Problems/EOT: Many Severe Problems | 0 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Moderate Problems/EOT: No Problem | 224 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Moderate Problems/EOT: Very Minor Problems | 447 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Moderate Problems/EOT: Minor Problems | 171 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Moderate Problems/EOT: Moderate Problems | 116 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Moderate Problems/EOT: Severe Problems | 3 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Moderate Problems/EOT: Many Severe Problems | 1 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Severe Problems/EOT: No Problem | 188 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Severe Problems/EOT: Very Minor Problems | 456 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Severe Problems/EOT: Minor Problems | 227 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Severe Problems/EOT: Moderate Problems | 97 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Severe Problems/EOT: Severe Problems | 49 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Severe Problems/EOT: Many Severe Problems | 0 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Many Severe Problems/EOT: No Problem | 105 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Many Severe Problems/EOT: Very Minor Problems | 195 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Many Severe Problems/EOT: Minor Problems | 148 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Many Severe Problems/EOT: Moderate Problems | 97 Participants |
| Toviaz | Participant Perception of Bladder Condition at the End of Study Treatment | BL: Many Severe Problems/EOT: Many Severe Problems | 19 Participants |
Secondary
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Participants who were assessed as having improved from their baseline condition in the final efficacy assessment were considered as effective. Baseline and treatment characteristics included: geriatric status (\<65 years or ≥65 years), age categories, gender, weight categories, height categories, allergic history, duration of disease, past overactive bladder (OAB) treatment history, medical history, kidney and liver disorders, concomitant medication, total administration period of Toviaz, completion status, daily dose of Toviaz, and long term administration of Toviaz (\<274 days and ≥274 days) .
Time frame: At the end of study treatment
Population: PP Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | All Participants | 90.13 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Geriatric Status: <65 years | 90.86 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Geriatric Status: ≥65 years | 89.20 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Age Category: <50 years | 91.27 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Age Category: 50 to 59 years | 91.08 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Age Category: 60 to 69 years | 89.29 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Age Category: 70 to 79 years | 89.45 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Age Category: ≥80 years | 89.27 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Gender: Male | 88.98 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Gender: Female | 91.36 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Weight Category: <50 kg | 89.73 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Weight Category: 50 to <60 kg | 91.64 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Weight Category: 60 to <70 kg | 90.32 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Weight Category: ≥70 kg | 88.82 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Height Category: <160 cm | 89.99 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Height Category: 160 to 170 cm | 90.32 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Height Category: ≥170 cm | 90.35 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Allergic History: Yes | 82.22 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Allergic History: No | 90.25 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Duration of Disease: <1 week | 92.40 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Duration of Disease: 1 to <8 weeks | 89.42 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Duration of Disease: 8 to <16 weeks | 89.05 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Duration of Disease: ≥16 weeks | 84.33 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Past OAB Treatment History: Yes | 85.30 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Past OAB Treatment History: No | 91.79 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Existence for Medical History of Past Disease: Yes | 87.96 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Existence for Medical History of Past Disease: No | 90.47 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Medical History of Present Disease: Yes | 87.96 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Medical History of Present Disease: No | 92.46 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Kidney Disease: Yes | 90.00 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Kidney Disease: No | 90.13 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Liver Disorder: Yes | 92.31 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Liver Disorder: No | 90.12 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Administration Period of Toviaz: <2 months | 85.22 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Administration Period of Toviaz: 2 to <4 months | 92.44 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Administration Period Of Toviaz: ≥ 4 months | 92.33 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Daily Dose of Toviaz: 3 mg | 66.67 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Daily Dose of Toviaz: 4 mg | 90.65 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Daily Dose of Toviaz: >4 to <8 mg | 85.25 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Daily Dose of Toviaz: 8 mg | 90.25 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Completion | 92.28 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Discontinuation | 80.72 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Total Administration Period <274 days | 90.16 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Total Administration Period ≥274 days | 87.50 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Existence for Concurrent Medication: Yes | 88.48 Percentage of Participants |
| Toviaz | Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Existence for Concurrent Medication: No | 92.08 Percentage of Participants |
Comparison: Geriatric Status: \<65 years versus (vs) Geriatric Status: ≥65 yearsp-value: 0.1319Chi-squared
Comparison: Comparison among Age Categories: \<50 years, 50 to 59 years, 60 to 69 years, 70 to 79 years, and ≥80 years.p-value: 0.601Chi-squared
Comparison: Male vs Femalep-value: 0.0289Chi-squared
Comparison: Comparison among Weight Categories: \<50 kg, 50 to 60 kg, 60 to 70 kg, and ≥70 kg.p-value: 0.3078Chi-squared
Comparison: Comparison among Height Categories: \<160 cm, 160 to 170 cm, and ≥170 cm.p-value: 0.9614Chi-squared
Comparison: Allergic History: Yes vs Allergic History: Nop-value: 0.0788Fisher Exact
Comparison: Comparison among Duration of Disease: \<1 week, 1 to 8 weeks, 8 to 16 weeks, and ≥16 weeks.p-value: <0.0001Chi-squared
Comparison: Past OAB Treatment History: Yes vs Past OAB Treatment History: Nop-value: <0.0001Chi-squared
Comparison: Medical History of Past Disease: Yes vs Medical History of Past Disease: Nop-value: 0.1147Chi-squared
Comparison: Medical History of Present Disease: Yes vs Medical History of Present Disease: Nop-value: <0.0001Chi-squared
Comparison: Kidney Disorder: Yes vs Kidney Disorder: Nop-value: 1Fisher Exact
Comparison: Liver Disorder: Yes vs Liver Disorder: Nop-value: 1Fisher Exact
Comparison: Comparison among Total Administration Period of Toviaz Subgroups: \<2 months, 2 to 4 months, and ≥4 months.p-value: <0.0001Chi-squared
Comparison: Comparison among Daily Dose of Toviaz: 3 mg, 4 mg, \>4 mg to \<8 mg, and 8 mg.p-value: 0.0239Fisher Exact
Comparison: Completion vs Discontinuationp-value: <0.0001Chi-squared
Comparison: Total Administration Period \<274 days vs Total Administration Period ≥ 274 daysp-value: 0.5889Fisher Exact
Comparison: Concurrent Medication: Yes vs Concurrent Medication: Nop-value: 0.001Chi-squared