Trial Outcomes & Findings for A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants With Diabetes (NCT NCT04288778)
NCT ID: NCT04288778
Last Updated: 2025-03-30
Results Overview
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. TEAEs were defined as events that started on or after the study medication start date and time.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
276 participants
Primary outcome timeframe
Baseline (Day 1) up to 24 weeks
Results posted on
2025-03-30
Participant Flow
Participant milestones
| Measure |
Canagliflozin + Metformin Hydrochloride FDC
Participants received either (canagliflozin 50 milligram \[mg\] + metformin hydrochloride 500 mg) or (canagliflozin 50 mg + metformin hydrochloride 1000 mg) immediate release (IR) fixed-dose combination (FDC) tablets twice daily (BD) up to Week 24.
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|---|---|
|
Overall Study
STARTED
|
276
|
|
Overall Study
Treated
|
274
|
|
Overall Study
COMPLETED
|
265
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Canagliflozin + Metformin Hydrochloride FDC
Participants received either (canagliflozin 50 milligram \[mg\] + metformin hydrochloride 500 mg) or (canagliflozin 50 mg + metformin hydrochloride 1000 mg) immediate release (IR) fixed-dose combination (FDC) tablets twice daily (BD) up to Week 24.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Non-Compliance With Study Drug
|
1
|
|
Overall Study
Other
|
1
|
|
Overall Study
Started but not treated
|
2
|
Baseline Characteristics
A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants With Diabetes
Baseline characteristics by cohort
| Measure |
Canagliflozin + Metformin Hydrochloride FDC
n=274 Participants
Participants received either (canagliflozin 50 milligram \[mg\] + metformin hydrochloride 500 mg) or (canagliflozin 50 mg + metformin hydrochloride 1000 mg) immediate release (IR) fixed-dose combination (FDC) tablets twice daily (BD) up to Week 24.
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|---|---|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 8.34 • n=93 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
168 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Indian
|
274 Participants
n=93 Participants
|
|
Region of Enrollment
India
|
274 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to 24 weeksPopulation: Safety analysis set included all participants who had taken at least 1 dose of study treatment.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. TEAEs were defined as events that started on or after the study medication start date and time.
Outcome measures
| Measure |
Canagliflozin + Metformin Hydrochloride FDC
n=274 Participants
Participants received either (canagliflozin 50 milligram \[mg\] + metformin hydrochloride 500 mg) or (canagliflozin 50 mg + metformin hydrochloride 1000 mg) immediate release (IR) fixed-dose combination (FDC) tablets twice daily (BD) up to Week 24.
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|---|---|
|
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TEAEs
|
41.6 Percentage of participants
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|
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TESAEs
|
1.1 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to 24 weeksPopulation: Safety analysis set included all participants who had taken at least 1 dose of study treatment.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An adverse event was considered unexpected if the nature or severity was not consistent with the applicable product reference safety information.
Outcome measures
| Measure |
Canagliflozin + Metformin Hydrochloride FDC
n=274 Participants
Participants received either (canagliflozin 50 milligram \[mg\] + metformin hydrochloride 500 mg) or (canagliflozin 50 mg + metformin hydrochloride 1000 mg) immediate release (IR) fixed-dose combination (FDC) tablets twice daily (BD) up to Week 24.
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|---|---|
|
Percentage of Participants With Unexpected Adverse Events (AEs)
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to 24 weeksPopulation: Safety analysis set included all participants who had taken at least 1 dose of study treatment.
ADRs were defined as the treatment related TEAEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs were defined as events that started on or after the study medication start date and time.
Outcome measures
| Measure |
Canagliflozin + Metformin Hydrochloride FDC
n=274 Participants
Participants received either (canagliflozin 50 milligram \[mg\] + metformin hydrochloride 500 mg) or (canagliflozin 50 mg + metformin hydrochloride 1000 mg) immediate release (IR) fixed-dose combination (FDC) tablets twice daily (BD) up to Week 24.
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|---|---|
|
Percentage of Participants With Adverse Drug Reactions (ADRs)
|
10.6 Percentage of participants
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SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: Efficacy analysis set included all participants who had taken at least 1 dose of study treatment and had both baseline and at least 1 post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable at the specified timepoints.
Percent change from baseline in HbA1c at Weeks 12 and 24 was reported.
Outcome measures
| Measure |
Canagliflozin + Metformin Hydrochloride FDC
n=265 Participants
Participants received either (canagliflozin 50 milligram \[mg\] + metformin hydrochloride 500 mg) or (canagliflozin 50 mg + metformin hydrochloride 1000 mg) immediate release (IR) fixed-dose combination (FDC) tablets twice daily (BD) up to Week 24.
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|---|---|
|
Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24
Percent change at Week 12
|
-0.918 Percent change
Standard Deviation 1.1348
|
|
Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24
Percent change at Week 24
|
-0.926 Percent change
Standard Deviation 1.3054
|
Adverse Events
Canagliflozin + Metformin Hydrochloride FDC
Serious events: 3 serious events
Other events: 114 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Canagliflozin + Metformin Hydrochloride FDC
n=274 participants at risk
Participants received either (canagliflozin 50 milligram \[mg\] + metformin hydrochloride 500 mg) or (canagliflozin 50 mg + metformin hydrochloride 1000 mg) immediate release (IR) fixed-dose combination (FDC) tablets twice daily (BD) up to Week 24.
|
|---|---|
|
Infections and infestations
COVID-19
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
0.73%
2/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Canagliflozin + Metformin Hydrochloride FDC
n=274 participants at risk
Participants received either (canagliflozin 50 milligram \[mg\] + metformin hydrochloride 500 mg) or (canagliflozin 50 mg + metformin hydrochloride 1000 mg) immediate release (IR) fixed-dose combination (FDC) tablets twice daily (BD) up to Week 24.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Cardiac disorders
Palpitations
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Cardiac disorders
Sinus Bradycardia
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Eye disorders
Cataract
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Eye disorders
Diabetic Retinal Oedema
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
1.1%
3/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.73%
2/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.73%
2/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
General disorders
Asthenia
|
1.8%
5/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
General disorders
Chest Pain
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
0.73%
2/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
General disorders
Pain
|
0.73%
2/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
4.7%
13/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19
|
1.8%
5/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Infections and infestations
Carbuncle
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Infections and infestations
Dengue Fever
|
0.73%
2/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Infections and infestations
Dysentery
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Infections and infestations
Fungal Infection
|
0.73%
2/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Infections and infestations
Fungal Skin Infection
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
1.1%
3/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Infections and infestations
Genital Infection
|
3.3%
9/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.73%
2/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Infections and infestations
Orchitis
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Infections and infestations
Tinea Cruris
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
2.6%
7/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Infections and infestations
Vaginal Infection
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Infections and infestations
Vulvovaginitis
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Investigations
Albumin Urine Present
|
1.5%
4/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Investigations
Blood Creatinine Increased
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Investigations
Blood Pressure Increased
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Investigations
Blood Triglycerides Increased
|
1.1%
3/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Investigations
Urine Albumin/Creatinine Ratio Increased
|
0.73%
2/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Investigations
Weight Decreased
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.73%
2/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
4.7%
13/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.73%
2/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.1%
3/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.3%
9/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Vitamin B12 Deficiency
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
5/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.73%
2/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.8%
5/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
1.5%
4/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness Exertional
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Nervous system disorders
Head Discomfort
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
1.5%
4/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Nervous system disorders
Lethargy
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
1.1%
3/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Albuminuria
|
1.1%
3/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
1.1%
3/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Microalbuminuria
|
1.1%
3/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Micturition Urgency
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
1.8%
5/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
1.5%
4/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Pruritus Genital
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Smegma Accumulation
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal Pruritus
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Pruritus
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.73%
2/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.36%
1/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.73%
2/274 • Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER