Trial Outcomes & Findings for Exploratory Trial of TAS-303 in Female Patients With Stress Urinary Incontinence (NCT NCT02906683)
NCT ID: NCT02906683
Last Updated: 2024-09-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
337 participants
Primary outcome timeframe
Baseline to Week 8 (8 weeks in treatment period)
Results posted on
2024-09-26
Participant Flow
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 Of the 386 patients who gave informed consent and received screening tests, 49 patients were withdrawn at screening.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.
Participant milestones
| Measure |
TAS-303 3 mg
Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks.
|
TAS-303 6 mg
Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks.
|
Placebo
Female patients with SUI orally received placebo once daily for 8 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
85
|
86
|
85
|
|
Overall Study
COMPLETED
|
84
|
81
|
82
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
3
|
Reasons for withdrawal
| Measure |
TAS-303 3 mg
Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks.
|
TAS-303 6 mg
Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks.
|
Placebo
Female patients with SUI orally received placebo once daily for 8 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
|
Overall Study
Patient did not meet the eligibility criteria for the study
|
1
|
0
|
0
|
|
Overall Study
Study treatment becomes impossible due to changing hospital or other reasons
|
0
|
1
|
1
|
Baseline Characteristics
Exploratory Trial of TAS-303 in Female Patients With Stress Urinary Incontinence
Baseline characteristics by cohort
| Measure |
TAS-303 3 mg
n=84 Participants
Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks.
|
TAS-303 6 mg
n=80 Participants
Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks.
|
Placebo
n=81 Participants
Female patients with SUI orally received placebo once daily for 8 weeks.
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.0 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
56.0 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
55.9 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 12.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
245 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
84 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
245 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
84 participants
n=5 Participants
|
80 participants
n=7 Participants
|
81 participants
n=5 Participants
|
245 participants
n=4 Participants
|
|
Type of Urinary Incontinence
Stress Urinary Incontinence (SUI)
|
63 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
185 Participants
n=4 Participants
|
|
Type of Urinary Incontinence
Mixed Urinary Incontinence (MUI)
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Prior surgery for pelvic organ prolapse
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Urinary Incontinence episodes of <2 per 24 hours
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Urinary Incontinence episodes of ≥2 per 24 hours
|
45 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Number of Urinary Incontinence episodes per 24 hours
|
2.853 episodes per 24hr
STANDARD_DEVIATION 2.322 • n=5 Participants
|
2.499 episodes per 24hr
STANDARD_DEVIATION 1.507 • n=7 Participants
|
2.582 episodes per 24hr
STANDARD_DEVIATION 1.673 • n=5 Participants
|
2.648 episodes per 24hr
STANDARD_DEVIATION 1.874 • n=4 Participants
|
|
1-hour Pad weight Test
|
33.85 gram
STANDARD_DEVIATION 70.98 • n=5 Participants
|
29.12 gram
STANDARD_DEVIATION 48.26 • n=7 Participants
|
37.92 gram
STANDARD_DEVIATION 60.49 • n=5 Participants
|
33.65 gram
STANDARD_DEVIATION 60.67 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8 (8 weeks in treatment period)Population: PPS was used for the analysis.
Outcome measures
| Measure |
TAS-303 3 mg
n=84 Participants
Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks.
|
TAS-303 6 mg
n=80 Participants
Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks.
|
Placebo
n=81 Participants
Female patients with SUI orally received placebo once daily for 8 weeks.
|
|---|---|---|---|
|
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8
IEF per 24 hours at baseline
|
2.9 episodes
Standard Deviation 2.3
|
2.5 episodes
Standard Deviation 1.5
|
2.6 episodes
Standard Deviation 1.7
|
|
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8
IEF per 24 hours at Week 8
|
2.0 episodes
Standard Deviation 2.3
|
1.7 episodes
Standard Deviation 1.7
|
1.9 episodes
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: Baseline to Week 8 (8 weeks in treatment period)Population: PPS was used for the analysis.
Outcome measures
| Measure |
TAS-303 3 mg
n=84 Participants
Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks.
|
TAS-303 6 mg
n=80 Participants
Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks.
|
Placebo
n=81 Participants
Female patients with SUI orally received placebo once daily for 8 weeks.
|
|---|---|---|---|
|
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8
|
-34.7 Percentage change
Standard Deviation 39.9
|
-35.4 Percentage change
Standard Deviation 39.0
|
-28.1 Percentage change
Standard Deviation 47.3
|
SECONDARY outcome
Timeframe: Baseline to Week 4 (4 weeks in treatment period)Population: PPS was used for the analysis.
Outcome measures
| Measure |
TAS-303 3 mg
n=84 Participants
Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks.
|
TAS-303 6 mg
n=80 Participants
Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks.
|
Placebo
n=81 Participants
Female patients with SUI orally received placebo once daily for 8 weeks.
|
|---|---|---|---|
|
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4
IEF per 24 hours at baseline
|
2.9 episodes
Standard Deviation 2.3
|
2.5 episodes
Standard Deviation 1.5
|
2.6 episodes
Standard Deviation 1.7
|
|
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4
IEF per 24 hours at Week 4
|
2.3 episodes
Standard Deviation 2.2
|
2.0 episodes
Standard Deviation 1.5
|
2.2 episodes
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline to Week 4 (4 weeks in treatment period)Population: PPS was used for the analysis.
Outcome measures
| Measure |
TAS-303 3 mg
n=83 Participants
Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks.
|
TAS-303 6 mg
n=79 Participants
Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks.
|
Placebo
n=81 Participants
Female patients with SUI orally received placebo once daily for 8 weeks.
|
|---|---|---|---|
|
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4
|
-23.1 Percentage change
Standard Deviation 37.3
|
-23.9 Percentage change
Standard Deviation 33.8
|
-11.7 Percentage change
Standard Deviation 45.4
|
SECONDARY outcome
Timeframe: Baseline to Week 4 (4 weeks in treatment period)Population: 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.
Outcome measures
| Measure |
TAS-303 3 mg
n=63 Participants
Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks.
|
TAS-303 6 mg
n=61 Participants
Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks.
|
Placebo
n=61 Participants
Female patients with SUI orally received placebo once daily for 8 weeks.
|
|---|---|---|---|
|
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup
IEF per 24 hours at Week 4
|
2.0 episodes
Standard Deviation 1.9
|
1.9 episodes
Standard Deviation 1.5
|
2.3 episodes
Standard Deviation 1.9
|
|
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup
IEF per 24 hours at baseline
|
2.7 episodes
Standard Deviation 2.4
|
2.5 episodes
Standard Deviation 1.5
|
2.6 episodes
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline to Week 4 (4 weeks in treatment period)Population: 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.
Outcome measures
| Measure |
TAS-303 3 mg
n=62 Participants
Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks.
|
TAS-303 6 mg
n=60 Participants
Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks.
|
Placebo
n=61 Participants
Female patients with SUI orally received placebo once daily for 8 weeks.
|
|---|---|---|---|
|
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 in SUI Subgroup
|
-26.5 Percentage change
Standard Deviation 34.8
|
-25.8 Percentage change
Standard Deviation 33.5
|
-8.9 Percentage change
Standard Deviation 46.3
|
SECONDARY outcome
Timeframe: Baseline to Week 8 (8 weeks in treatment period)Population: 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.
Outcome measures
| Measure |
TAS-303 3 mg
n=63 Participants
Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks.
|
TAS-303 6 mg
n=61 Participants
Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks.
|
Placebo
n=61 Participants
Female patients with SUI orally received placebo once daily for 8 weeks.
|
|---|---|---|---|
|
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup
IEF per 24 hours at baseline
|
2.7 episodes
Standard Deviation 2.4
|
2.5 episodes
Standard Deviation 1.5
|
2.6 episodes
Standard Deviation 1.7
|
|
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup
IEF per 24 hours at Week 8
|
1.8 episodes
Standard Deviation 2.1
|
1.8 episodes
Standard Deviation 1.8
|
2.0 episodes
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline to Week 8 (8 weeks in treatment period)Population: 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.
Outcome measures
| Measure |
TAS-303 3 mg
n=63 Participants
Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks.
|
TAS-303 6 mg
n=61 Participants
Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks.
|
Placebo
n=61 Participants
Female patients with SUI orally received placebo once daily for 8 weeks.
|
|---|---|---|---|
|
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 in SUI Subgroup
|
-37.4 Percentage change
Standard Deviation 33.1
|
-35.7 Percentage change
Standard Deviation 37.8
|
-26.1 Percentage change
Standard Deviation 47.8
|
SECONDARY outcome
Timeframe: At Week 8 in the treatment periodPopulation: PPS was used for the analysis.
Outcome measures
| Measure |
TAS-303 3 mg
n=84 Participants
Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks.
|
TAS-303 6 mg
n=80 Participants
Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks.
|
Placebo
n=81 Participants
Female patients with SUI orally received placebo once daily for 8 weeks.
|
|---|---|---|---|
|
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
|
25 Participants
|
27 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8 (8 weeks in treatment period)Population: PPS was used for the analysis.
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".
Outcome measures
| Measure |
TAS-303 3 mg
n=84 Participants
Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks.
|
TAS-303 6 mg
n=80 Participants
Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks.
|
Placebo
n=81 Participants
Female patients with SUI orally received placebo once daily for 8 weeks.
|
|---|---|---|---|
|
Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8
Baseline
|
28 Participants
|
29 Participants
|
26 Participants
|
|
Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8
Week 4
|
49 Participants
|
58 Participants
|
44 Participants
|
|
Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8
Week 8
|
61 Participants
|
55 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8 (8 weeks in treatment period)Population: 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.
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.
Outcome measures
| Measure |
TAS-303 3 mg
n=85 Participants
Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks.
|
TAS-303 6 mg
n=86 Participants
Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks.
|
Placebo
n=85 Participants
Female patients with SUI orally received placebo once daily for 8 weeks.
|
|---|---|---|---|
|
Any Adverse Events
Musculoskeletal pain
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Any Adverse Events
Myalgia
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Any Adverse Events
Tenosynovitis
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Any Adverse Events
Headache
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Any Adverse Events
Sleep disorder
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Proteinuria
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Any Adverse Events
Hypotonic urinary bladder
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Any Adverse Events
Cough
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Any Adverse Events
Upper respiratory tract inflammation
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Oropharyngeal pain
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Any Adverse Events
Dermatitis atopic
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Dermatitis contact
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Any Adverse Events
Eczema
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Any Adverse Events
Rash
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Skin discomfort
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Any Adverse Events
Hypertension
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Any adverse events
|
31 Participants
|
20 Participants
|
26 Participants
|
|
Any Adverse Events
Palpitations
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Vertigo
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Any Adverse Events
Sudden hearing loss
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Any Adverse Events
Abdominal pain lower
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Constipation
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Any Adverse Events
Dental caries
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Any Adverse Events
Diarrhoea
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Any Adverse Events
Gastritis
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Any Adverse Events
Nausea
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Any Adverse Events
Stomatitis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Vomiting
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Any Adverse Events
Malaise
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Any Adverse Events
Pyrexia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Any Adverse Events
Thirst
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Any Adverse Events
Allergy to arthropod bite
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Any Adverse Events
Bronchitis
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Any Adverse Events
Cystitis
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Any Adverse Events
Gingivitis
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Any Adverse Events
Herpes zoster
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Any Adverse Events
Hordeolum
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Influenza
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Nasopharyngitis
|
9 Participants
|
4 Participants
|
8 Participants
|
|
Any Adverse Events
Otitis media
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Periodontitis
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Any Adverse Events
Pyuria
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Upper respiratory tract infection
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Cystitis bacterial
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Any Adverse Events
Arthropod sting
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Any Adverse Events
Muscle injury
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Radius fracture
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Any Adverse Events
Spinal compression fracture
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Any Adverse Events
Wound
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Any Adverse Events
Skin injury
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Any Adverse Events
Ear abrasion
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Alanine aminotransferase increased
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Aspartate aminotransferase increased
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Blood creatine phosphokinase increased
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Any Adverse Events
Blood potassium increased
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Any Adverse Events
C-reactive protein increased
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Any Adverse Events
Electrocardiogram QT prolonged
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Eosinophil count increased
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Any Adverse Events
White blood cell count increased
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Liver function test increased
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Dyslipidaemia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Any Adverse Events
Decreased appetite
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Any Adverse Events
Arthralgia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Any Adverse Events
Back pain
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8 (8 weeks in treatment period)Population: 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.
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.
Outcome measures
| Measure |
TAS-303 3 mg
n=85 Participants
Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks.
|
TAS-303 6 mg
n=86 Participants
Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks.
|
Placebo
n=85 Participants
Female patients with SUI orally received placebo once daily for 8 weeks.
|
|---|---|---|---|
|
Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period
Nasopharyngitis
|
9 Participants
|
4 Participants
|
8 Participants
|
|
Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period
Cystitis
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period
Constipation
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period
Diarrhoea
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period
Decreased appetite
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period
Headache
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period
Cough
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period
Alanine aminotransferase increased
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period
Eczema
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8 (8 weeks in treatment period)Population: 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.
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.
Outcome measures
| Measure |
TAS-303 3 mg
n=85 Participants
Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks.
|
TAS-303 6 mg
n=86 Participants
Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks.
|
Placebo
n=85 Participants
Female patients with SUI orally received placebo once daily for 8 weeks.
|
|---|---|---|---|
|
Adverse Drug Reactions
White blood cell count increased
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Drug Reactions
Liver function test increased
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Drug Reactions
Rash
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Drug Reactions
Any Events
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Drug Reactions
Constipation
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Drug Reactions
Alanine aminotransferase increased
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Drug Reactions
Aspartate aminotransferase increased
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Drug Reactions
Blood creatine phosphokinase increased
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8 (8 weeks in treatment period)Population: 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.
Outcome measures
| Measure |
TAS-303 3 mg
n=85 Participants
Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks.
|
TAS-303 6 mg
n=86 Participants
Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks.
|
Placebo
n=85 Participants
Female patients with SUI orally received placebo once daily for 8 weeks.
|
|---|---|---|---|
|
Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8 (8 weeks in treatment period)Population: 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.
Outcome measures
| Measure |
TAS-303 3 mg
n=85 Participants
Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks.
|
TAS-303 6 mg
n=86 Participants
Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks.
|
Placebo
n=85 Participants
Female patients with SUI orally received placebo once daily for 8 weeks.
|
|---|---|---|---|
|
Adverse Events Leading to Discontinuation of Administration
Any adverse events leading to discontinuation of administration
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events Leading to Discontinuation of Administration
Radius fracture
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events Leading to Discontinuation of Administration
Spinal compression fracture
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
TAS-303 3 mg
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
TAS-303 6 mg
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TAS-303 3 mg
n=85 participants at risk
Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks.
|
TAS-303 6 mg
n=86 participants at risk
Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks.
|
Placebo
n=85 participants at risk
Female patients with SUI orally received placebo once daily for 8 weeks.
|
|---|---|---|---|
|
Infections and infestations
Cystitis
|
2.4%
2/85 • Number of events 2 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/85 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
Infections and infestations
Herpes zoster
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
Infections and infestations
Hordeolum
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Infections and infestations
Influenza
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
10.6%
9/85 • Number of events 9 • 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.
|
4.7%
4/86 • Number of events 4 • 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.
|
9.4%
8/85 • Number of events 9 • 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.
|
|
Infections and infestations
Otitis media
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/85 • 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.
|
1.2%
1/86 • Number of events 1 • 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.
|
0.00%
0/85 • 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.
|
|
Infections and infestations
Pyuria
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Infections and infestations
Cystitis bacterial
|
0.00%
0/85 • 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.
|
1.2%
1/86 • Number of events 1 • 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.
|
0.00%
0/85 • 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.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/85 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/85 • 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.
|
1.2%
1/86 • Number of events 1 • 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.
|
0.00%
0/85 • 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.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/85 • 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.
|
1.2%
1/86 • Number of events 1 • 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.
|
0.00%
0/85 • 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.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/85 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/85 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Ear abrasion
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
2/85 • Number of events 2 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Investigations
Aspartate aminotransferase increased
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.2%
1/85 • Number of events 1 • 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.
|
1.2%
1/86 • Number of events 1 • 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.
|
0.00%
0/85 • 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.
|
|
Investigations
Blood potassium increased
|
0.00%
0/85 • 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.
|
1.2%
1/86 • Number of events 1 • 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.
|
0.00%
0/85 • 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.
|
|
Investigations
C-reactive protein increased
|
1.2%
1/85 • Number of events 1 • 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.
|
1.2%
1/86 • Number of events 1 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
Investigations
Electrocardiogram QT prolonged
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/85 • 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.
|
1.2%
1/86 • Number of events 1 • 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.
|
0.00%
0/85 • 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.
|
|
Investigations
White blood cell count increased
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Investigations
Liver function test increased
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/85 • 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.
|
2.3%
2/86 • Number of events 2 • 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.
|
0.00%
0/85 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/85 • 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.
|
1.2%
1/86 • Number of events 1 • 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.
|
0.00%
0/85 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/85 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/85 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
Nervous system disorders
Headache
|
0.00%
0/85 • 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.
|
2.3%
2/86 • Number of events 2 • 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.
|
0.00%
0/85 • 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.
|
|
Psychiatric disorders
Sleep disorder
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/85 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
Renal and urinary disorders
Hypotonic urinary bladder
|
0.00%
0/85 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/85 • 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.
|
2.3%
2/86 • Number of events 2 • 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.
|
0.00%
0/85 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/85 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/85 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/85 • 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.
|
0.00%
0/86 • 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.
|
2.4%
2/85 • Number of events 2 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Skin and subcutaneous tissue disorders
Skin discomfort
|
0.00%
0/85 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
Vascular disorders
Hypertension
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Cardiac disorders
Palpitations
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/85 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/85 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Gastrointestinal disorders
Constipation
|
2.4%
2/85 • Number of events 2 • 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.
|
1.2%
1/86 • Number of events 1 • 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.
|
0.00%
0/85 • 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.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/85 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/85 • 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.
|
2.3%
2/86 • Number of events 2 • 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.
|
0.00%
0/85 • 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.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/85 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/85 • 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.
|
1.2%
1/86 • Number of events 1 • 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.
|
0.00%
0/85 • 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.
|
|
Gastrointestinal disorders
Stomatitis
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
0.00%
0/85 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/85 • Number of events 1 • 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.
|
0.00%
0/86 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
|
General disorders
Malaise
|
0.00%
0/85 • 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.
|
1.2%
1/86 • Number of events 1 • 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.
|
0.00%
0/85 • 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.
|
|
General disorders
Pyrexia
|
0.00%
0/85 • 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.
|
1.2%
1/86 • Number of events 1 • 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.
|
0.00%
0/85 • 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.
|
|
General disorders
Thirst
|
1.2%
1/85 • Number of events 1 • 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.
|
1.2%
1/86 • Number of events 1 • 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.
|
0.00%
0/85 • 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.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/85 • 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.
|
1.2%
1/86 • Number of events 1 • 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.
|
0.00%
0/85 • 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.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/85 • 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.
|
1.2%
1/86 • Number of events 1 • 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.
|
1.2%
1/85 • Number of events 1 • 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.
|
Additional Information
Taiho Pharmaceutical Co., Ltd.
Clinical Trial Registration Contact
Phone: +81-3-3293-2455
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place