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The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female patients with stress urinary incontinence.
The main purpose of this study is to assess the efficacy of TAS-303 for 8 weeks in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in incontinence episode frequency (IEF) from baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAS-303 3mg | Experimental |
| |
| TAS-303 6mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAS-303 | Drug | Oral administration for 8 weeks, once daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 | Baseline to Week 8 (8 weeks in treatment period) | |
| Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 | Baseline to Week 8 (8 weeks in treatment period) |
| Measure | Description | Time Frame |
|---|---|---|
| Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 | Baseline to Week 4 (4 weeks in treatment period) | |
| Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 | Baseline to Week 4 (4 weeks in treatment period) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taiho Pharmaceutical Co., Ltd | Taiho Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taiho Pharmaceutical Co., Ltd selected site | Osaka | Japan |
Not provided
This study was undertaken at 31 centers in Japan between 17 October 2016 and 25 April 2018.
Of the 386 patients who gave informed consent and received screening tests, 49 patients were withdrawn at screening. The number of patients enrolled in the observation period was 337 patients, but after the end of the observation period, 256 patients were deemed to be eligible for enrollment in the treatment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAS-303 3 mg | Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks. |
| FG001 | TAS-303 6 mg | Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks. |
| FG002 | Placebo | Female patients with SUI orally received placebo once daily for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Per protocol set (PPS) was used for the analysis. PPS included patients in the Full analysis set (FAS) who had no inclusion/exclusion criteria violations, received no prohibited concomitant medications or therapy; were compliant for ≥ 80% of the treatment period and completed ≥ 70% of Bladder diary at Week 8 in the treatment period. FAS included all patients who received the study drug and had ≥ 1 available efficacy endpoint before and during the treatment period.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TAS-303 3 mg | Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks. |
| BG001 | TAS-303 6 mg | Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 | PPS was used for the analysis. | Posted | Mean | Standard Deviation | episodes | Baseline to Week 8 (8 weeks in treatment period) |
|
Baseline to Week 8 (8 weeks in treatment period)
All treated population was used for the analysis. This analysis set includes all patients enrolled in the observation period who received at least 1 dose of the study drug.
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 | TAS-303 3 mg | Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taiho Pharmaceutical Co., Ltd. | Clinical Trial Registration Contact | +81-3-3293-2455 | toiawase@taiho.co.jp |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 16, 2016 | Aug 24, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 4, 2018 | Aug 24, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D014549 | Urinary Incontinence |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718062 | TAS-303 |
Not provided
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| Placebo |
| Drug |
Oral administration for 8 weeks, once daily. |
|
| Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup | Baseline to Week 4 (4 weeks in treatment period) |
| Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 in SUI Subgroup | Baseline to Week 4 (4 weeks in treatment period) |
| Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup | Baseline to Week 8 (8 weeks in treatment period) |
| Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 in SUI Subgroup | Baseline to Week 8 (8 weeks in treatment period) |
| Percentages of the Patients With an Incontinence Amount of ≤ 2.0 g (Deemed Dryness) in the 1-hour Pad Test at Week 8 in the Treatment Period | At Week 8 in the treatment period |
| Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8 | PGI-I was used to evaluate the patients' impression of improvement of urinary incontinence. The improvement of PGI-I was defined as the selection of "Very much better", "Much better", or "A little better". The investigator or subinvestigator instructed patients to evaluate the improvement of urinary incontinence at the evaluation time point using the following 7-point scale: (1) "Very much better"; (2) "Much better"; (3) "A little better"; (4) "No change"; (5) "A little worse"; (6) "Much worse"; and (7) "Very much worse". | Baseline to Week 8 (8 weeks in treatment period) |
| Any Adverse Events | For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA. | Baseline to Week 8 (8 weeks in treatment period) |
| Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA. | Baseline to Week 8 (8 weeks in treatment period) |
| Adverse Drug Reactions | For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA. | Baseline to Week 8 (8 weeks in treatment period) |
| Serious Adverse Events | Baseline to Week 8 (8 weeks in treatment period) |
| Adverse Events Leading to Discontinuation of Administration | Baseline to Week 8 (8 weeks in treatment period) |
| Withdrawal by Subject |
|
| Patient did not meet the eligibility criteria for the study |
|
| Study treatment becomes impossible due to changing hospital or other reasons |
|
| BG002 | Placebo | Female patients with SUI orally received placebo once daily for 8 weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type of Urinary Incontinence | Count of Participants | Participants |
|
| Prior surgery for pelvic organ prolapse | Count of Participants | Participants |
|
| Urinary Incontinence episodes of <2 per 24 hours | Count of Participants | Participants |
|
| Urinary Incontinence episodes of ≥2 per 24 hours | Count of Participants | Participants |
|
| Number of Urinary Incontinence episodes per 24 hours | Mean | Standard Deviation | episodes per 24hr |
|
| 1-hour Pad weight Test | 1-hour Pad weight Test is a one hour test for measuring urinary incontinence. Patients were instructed to wear incontinence pads capable of retaining a certain amount (≥200mL) of urine leakage and to perform urinary incontinence-inducible activities (7 activities including walking and climbing stairs) for one hour. After 1-hour activity, the amount of urinary incontinence was evaluated by measuring the incontinence pad. Dryness (no incontinence) is defined as a pad weight of ≤2.0 g in this test. | Mean | Standard Deviation | gram |
|
Female patients with SUI orally received placebo once daily for 8 weeks.
|
|
| Primary | Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 | PPS was used for the analysis. | Posted | Mean | Standard Deviation | Percentage change | Baseline to Week 8 (8 weeks in treatment period) |
|
|
|
|
| Secondary | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 | PPS was used for the analysis. | Posted | Mean | Standard Deviation | episodes | Baseline to Week 4 (4 weeks in treatment period) |
|
|
|
| Secondary | Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 | PPS was used for the analysis. | Posted | Mean | Standard Deviation | Percentage change | Baseline to Week 4 (4 weeks in treatment period) |
|
|
|
|
| Secondary | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup | PPS was used for the analysis. This analysis was conducted in SUI subgroup. This subgroup includes patients with only SUI but excludes those with MUI. | Posted | Mean | Standard Deviation | episodes | Baseline to Week 4 (4 weeks in treatment period) |
|
|
|
| Secondary | Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 in SUI Subgroup | PPS was used for the analysis. This analysis was conducted in SUI subgroup. This subgroup includes patients with only SUI but excludes those with MUI. | Posted | Mean | Standard Deviation | Percentage change | Baseline to Week 4 (4 weeks in treatment period) |
|
|
|
|
| Secondary | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup | PPS was used for the analysis. This analysis was conducted in SUI subgroup. This subgroup includes patients with only SUI but excludes those with MUI. | Posted | Mean | Standard Deviation | episodes | Baseline to Week 8 (8 weeks in treatment period) |
|
|
|
| Secondary | Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 in SUI Subgroup | PPS was used for the analysis. This analysis was conducted in SUI subgroup. This subgroup includes patients with only SUI but excludes those with MUI. | Posted | Mean | Standard Deviation | Percentage change | Baseline to Week 8 (8 weeks in treatment period) |
|
|
|
|
| Secondary | Percentages of the Patients With an Incontinence Amount of ≤ 2.0 g (Deemed Dryness) in the 1-hour Pad Test at Week 8 in the Treatment Period | PPS was used for the analysis. | Posted | Count of Participants | Participants | At Week 8 in the treatment period |
|
|
|
| Secondary | Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8 | PGI-I was used to evaluate the patients' impression of improvement of urinary incontinence. The improvement of PGI-I was defined as the selection of "Very much better", "Much better", or "A little better". The investigator or subinvestigator instructed patients to evaluate the improvement of urinary incontinence at the evaluation time point using the following 7-point scale: (1) "Very much better"; (2) "Much better"; (3) "A little better"; (4) "No change"; (5) "A little worse"; (6) "Much worse"; and (7) "Very much worse". | PPS was used for the analysis. | Posted | Count of Participants | Participants | Baseline to Week 8 (8 weeks in treatment period) |
|
|
|
| Secondary | Any Adverse Events | For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA. | All treated population was used for the analysis. This analysis set includes all patients enrolled in the observation period who received at least 1 dose of the study drug. | Posted | Count of Participants | Participants | Baseline to Week 8 (8 weeks in treatment period) |
|
|
|
| Secondary | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA. | All treated population was used for the analysis. This analysis set includes all patients enrolled in the observation period who received at least 1 dose of the study drug. | Posted | Count of Participants | Participants | Baseline to Week 8 (8 weeks in treatment period) |
|
|
|
| Secondary | Adverse Drug Reactions | For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA. | All treated population was used for the analysis. This analysis set includes all patients enrolled in the observation period who received at least 1 dose of the study drug. | Posted | Count of Participants | Participants | Baseline to Week 8 (8 weeks in treatment period) |
|
|
|
| Secondary | Serious Adverse Events | All treated population was used for the analysis. This analysis set includes all patients enrolled in the observation period who received at least 1 dose of the study drug. | Posted | Count of Participants | Participants | Baseline to Week 8 (8 weeks in treatment period) |
|
|
|
| Secondary | Adverse Events Leading to Discontinuation of Administration | All treated population was used for the analysis. This analysis set includes all patients enrolled in the observation period who received at least 1 dose of the study drug. | Posted | Count of Participants | Participants | Baseline to Week 8 (8 weeks in treatment period) |
|
|
|
| 0 |
| 85 |
| 0 |
| 85 |
| 31 |
| 85 |
| EG001 | TAS-303 6 mg | Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks. | 0 | 86 | 0 | 86 | 20 | 86 |
| EG002 | Placebo | Female patients with SUI orally received placebo once daily for 8 weeks. | 0 | 85 | 0 | 85 | 26 | 85 |
| Vertigo | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Allergy to arthropod bite | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pyuria | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Cystitis bacterial | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Muscle injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Ear abrasion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypotonic urinary bladder | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Skin discomfort | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8
| t-test, 2 sided |
| 0.285 |
| Mean Difference (Final Values) |
| -7.3 |
| Standard Error of the Mean |
| 6.84 |
| 2-Sided |
| 95 |
| -20.9 |
| 6.2 |
| Superiority |
| IEF per 24 hours at Week 4 |
|
|
TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4
| t-test, 2 sided |
| 0.057 |
| Mean Difference (Final Values) |
| -12.1 |
| Standard Error of the Mean |
| 6.34 |
| 2-Sided |
| 95 |
| -24.7 |
| 0.4 |
| Superiority |
| IEF per 24 hours at Week 4 |
|
|
TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4
| t-test, 2 sided |
| 0.023 |
| Mean Difference (Final Values) |
| -16.9 |
| Standard Error of the Mean |
| 7.36 |
| 2-Sided |
| 95 |
| -31.5 |
| -2.3 |
| Superiority |
|
TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8
| t-test, 2 sided |
| 0.221 |
| Mean Difference (Final Values) |
| -9.6 |
| Standard Error of the Mean |
| 7.80 |
| 2-Sided |
| 95 |
| -25.1 |
| 5.9 |
| Superiority |
| Title | Measurements |
|---|---|
|
| Week 8 |
|
| Title | Measurements |
|---|---|
|
| Vertigo |
|
| Sudden hearing loss |
|
| Abdominal pain lower |
|
| Constipation |
|
| Dental caries |
|
| Diarrhoea |
|
| Gastritis |
|
| Nausea |
|
| Stomatitis |
|
| Vomiting |
|
| Malaise |
|
| Pyrexia |
|
| Thirst |
|
| Allergy to arthropod bite |
|
| Bronchitis |
|
| Cystitis |
|
| Gingivitis |
|
| Herpes zoster |
|
| Hordeolum |
|
| Influenza |
|
| Nasopharyngitis |
|
| Otitis media |
|
| Periodontitis |
|
| Pyuria |
|
| Upper respiratory tract infection |
|
| Cystitis bacterial |
|
| Arthropod sting |
|
| Muscle injury |
|
| Radius fracture |
|
| Spinal compression fracture |
|
| Wound |
|
| Skin injury |
|
| Ear abrasion |
|
| Alanine aminotransferase increased |
|
| Aspartate aminotransferase increased |
|
| Blood creatine phosphokinase increased |
|
| Blood potassium increased |
|
| C-reactive protein increased |
|
| Electrocardiogram QT prolonged |
|
| Eosinophil count increased |
|
| White blood cell count increased |
|
| Liver function test increased |
|
| Dyslipidaemia |
|
| Decreased appetite |
|
| Arthralgia |
|
| Back pain |
|
| Musculoskeletal pain |
|
| Myalgia |
|
| Tenosynovitis |
|
| Headache |
|
| Sleep disorder |
|
| Proteinuria |
|
| Hypotonic urinary bladder |
|
| Cough |
|
| Upper respiratory tract inflammation |
|
| Oropharyngeal pain |
|
| Dermatitis atopic |
|
| Dermatitis contact |
|
| Eczema |
|
| Rash |
|
| Skin discomfort |
|
| Hypertension |
|
| Title | Measurements |
|---|---|
|
| Constipation |
|
| Diarrhoea |
|
| Decreased appetite |
|
| Headache |
|
| Cough |
|
| Alanine aminotransferase increased |
|
| Eczema |
|
| Title | Measurements |
|---|---|
|
| Alanine aminotransferase increased |
|
| Aspartate aminotransferase increased |
|
| Blood creatine phosphokinase increased |
|
| White blood cell count increased |
|
| Liver function test increased |
|
| Rash |
|
|
| Spinal compression fracture |
|