Trial Outcomes & Findings for A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension (NCT NCT06168409)
NCT ID: NCT06168409
Last Updated: 2026-08-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
218 participants
Primary outcome timeframe
Baseline to week 12
Results posted on
2026-08-06
Participant Flow
218 patients were randomised: 109 to baxdrostat 2 mg and 109 to placebo; however, one patient randomised to baxdrostat never received study intervention.
Participant milestones
| Measure |
Baxdrostat 2 mg
Baxdrostat 2 mg
|
Placebo
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
109
|
109
|
|
Overall Study
Started Study Intervention
|
108
|
109
|
|
Overall Study
COMPLETED
|
103
|
104
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Baxdrostat 2 mg
Baxdrostat 2 mg
|
Placebo
Placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Any other reason
|
6
|
3
|
Baseline Characteristics
Double-blind treatment period
Baseline characteristics by cohort
| Measure |
Baxdrostat 2 mg
n=108 Participants
Baxdrostat 2 mg
|
Placebo
n=109 Participants
Placebo
|
Total
n=217 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age (years)
|
59.4 Age (years)
STANDARD_DEVIATION 11.2 • n=20 Participants
|
59.7 Age (years)
STANDARD_DEVIATION 12.4 • n=20 Participants
|
59.6 Age (years)
STANDARD_DEVIATION 11.8 • n=40 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=20 Participants
|
39 Participants
n=20 Participants
|
77 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=20 Participants
|
70 Participants
n=20 Participants
|
140 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
35 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=20 Participants
|
84 Participants
n=20 Participants
|
170 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Region of Enrollment
ARG
|
12 Participants
n=20 Participants • Double-blind treatment period
|
13 Participants
n=20 Participants • Double-blind treatment period
|
25 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
AUS
|
2 Participants
n=20 Participants • Double-blind treatment period
|
6 Participants
n=20 Participants • Double-blind treatment period
|
8 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
BEL
|
0 Participants
n=20 Participants • Double-blind treatment period
|
1 Participants
n=20 Participants • Double-blind treatment period
|
1 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
BGR
|
8 Participants
n=20 Participants • Double-blind treatment period
|
11 Participants
n=20 Participants • Double-blind treatment period
|
19 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
CAN
|
0 Participants
n=20 Participants • Double-blind treatment period
|
4 Participants
n=20 Participants • Double-blind treatment period
|
4 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
CZE
|
6 Participants
n=20 Participants • Double-blind treatment period
|
4 Participants
n=20 Participants • Double-blind treatment period
|
10 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
DEU
|
2 Participants
n=20 Participants • Double-blind treatment period
|
1 Participants
n=20 Participants • Double-blind treatment period
|
3 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
ESP
|
5 Participants
n=20 Participants • Double-blind treatment period
|
3 Participants
n=20 Participants • Double-blind treatment period
|
8 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
GBR
|
9 Participants
n=20 Participants • Double-blind treatment period
|
9 Participants
n=20 Participants • Double-blind treatment period
|
18 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
GRC
|
7 Participants
n=20 Participants • Double-blind treatment period
|
10 Participants
n=20 Participants • Double-blind treatment period
|
17 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
HUN
|
3 Participants
n=20 Participants • Double-blind treatment period
|
0 Participants
n=20 Participants • Double-blind treatment period
|
3 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
MYS
|
3 Participants
n=20 Participants • Double-blind treatment period
|
0 Participants
n=20 Participants • Double-blind treatment period
|
3 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
PHL
|
1 Participants
n=20 Participants • Double-blind treatment period
|
2 Participants
n=20 Participants • Double-blind treatment period
|
3 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
POL
|
8 Participants
n=20 Participants • Double-blind treatment period
|
5 Participants
n=20 Participants • Double-blind treatment period
|
13 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
SAU
|
3 Participants
n=20 Participants • Double-blind treatment period
|
3 Participants
n=20 Participants • Double-blind treatment period
|
6 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
SVK
|
2 Participants
n=20 Participants • Double-blind treatment period
|
1 Participants
n=20 Participants • Double-blind treatment period
|
3 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
THA
|
4 Participants
n=20 Participants • Double-blind treatment period
|
4 Participants
n=20 Participants • Double-blind treatment period
|
8 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
TUR
|
10 Participants
n=20 Participants • Double-blind treatment period
|
9 Participants
n=20 Participants • Double-blind treatment period
|
19 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
TWN
|
4 Participants
n=20 Participants • Double-blind treatment period
|
2 Participants
n=20 Participants • Double-blind treatment period
|
6 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
USA
|
15 Participants
n=20 Participants • Double-blind treatment period
|
12 Participants
n=20 Participants • Double-blind treatment period
|
27 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
VNM
|
2 Participants
n=20 Participants • Double-blind treatment period
|
7 Participants
n=20 Participants • Double-blind treatment period
|
9 Participants
n=40 Participants • Double-blind treatment period
|
|
Region of Enrollment
ZAF
|
2 Participants
n=20 Participants • Double-blind treatment period
|
2 Participants
n=20 Participants • Double-blind treatment period
|
4 Participants
n=40 Participants • Double-blind treatment period
|
PRIMARY outcome
Timeframe: Baseline to week 12Population: Only patients that were randomised and treated, and with data collected at both baseline and week 12 are included in analysis.
Outcome measures
| Measure |
Baxdrostat 2 mg
n=89 Participants
Baxdrostat 2 mg
|
Placebo
n=95 Participants
Placebo
|
|---|---|---|
|
Least Square Mean Difference for Change From Baseline in Ambulatory 24-hour Average SBP at Week 12: Treatment Policy Strategy
|
-16.6 mmHg
Interval -18.8 to -14.3
|
-2.6 mmHg
Interval -4.7 to -0.4
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Patients that were randomised and treated, and with data collected at both baseline and week 12 are included in analysis.
Outcome measures
| Measure |
Baxdrostat 2 mg
n=89 Participants
Baxdrostat 2 mg
|
Placebo
n=95 Participants
Placebo
|
|---|---|---|
|
Change From Baseline in Ambulatory Night-time Average SBP (mmHg) at Week 12 LS Means
|
-16.0 mmHg
Interval -18.6 to -13.4
|
-2.1 mmHg
Interval -4.6 to 0.4
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Patients that were randomised and treated, and with data collected at both baseline and week 12 are included in analysis.
Outcome measures
| Measure |
Baxdrostat 2 mg
n=89 Participants
Baxdrostat 2 mg
|
Placebo
n=95 Participants
Placebo
|
|---|---|---|
|
Change From Baseline in Ambulatory Daytime Average SBP (mmHg) at Week 12
|
-16.8 mmHg
Interval -19.2 to -14.4
|
-2.7 mmHg
Interval -5.1 to -0.4
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Patients that were randomised and treated, and with data collected at baseline are included in analysis.
Outcome measures
| Measure |
Baxdrostat 2 mg
n=108 Participants
Baxdrostat 2 mg
|
Placebo
n=109 Participants
Placebo
|
|---|---|---|
|
Change From Baseline in Seated SBP (mmHg) at Week 12
|
-14.9 mmHg
Interval -18.2 to -11.6
|
-4.7 mmHg
Interval -7.9 to -1.4
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Only patients that were randomised and treated, and with data collected at both baseline and week 12 are included in analysis.
Outcome measures
| Measure |
Baxdrostat 2 mg
n=85 Participants
Baxdrostat 2 mg
|
Placebo
n=84 Participants
Placebo
|
|---|---|---|
|
Achieving Ambulatory 24-hour Average SBP of < 130 mmHg at Week 12
|
60 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Only patients that were randomised and treated, and with data collected at both baseline and week 12 are included in analysis.
Outcome measures
| Measure |
Baxdrostat 2 mg
n=89 Participants
Baxdrostat 2 mg
|
Placebo
n=95 Participants
Placebo
|
|---|---|---|
|
Change From Baseline in Ambulatory 24-hour Average DBP (mmHg) at Week 12
|
-8.3 mmHg
Interval -9.7 to -6.9
|
-1.5 mmHg
Interval -2.9 to -0.1
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Patients that were randomised and treated, and with data collected at both baseline and week 12 are included in analysis.
Outcome measures
| Measure |
Baxdrostat 2 mg
n=89 Participants
Baxdrostat 2 mg
|
Placebo
n=95 Participants
Placebo
|
|---|---|---|
|
Change From Baseline in Ambulatory Night-time Average DBP (mmHg) at Week 12
|
-7.9 mmHg
Interval -9.6 to -6.3
|
-1.1 mmHg
Interval -2.7 to 0.5
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Patients that were randomised and treated, and with data collected at both baseline and week 12 are included in analysis.
Outcome measures
| Measure |
Baxdrostat 2 mg
n=89 Participants
Baxdrostat 2 mg
|
Placebo
n=95 Participants
Placebo
|
|---|---|---|
|
Change From Baseline in Ambulatory Daytime Average DBP (mmHg) at Week 12
|
-8.4 mmHg
Interval -9.9 to -6.9
|
-1.7 mmHg
Interval -3.2 to -0.3
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Patients that were randomised and treated, and with data collected at baseline are included in analysis.
Outcome measures
| Measure |
Baxdrostat 2 mg
n=107 Participants
Baxdrostat 2 mg
|
Placebo
n=108 Participants
Placebo
|
|---|---|---|
|
Change From Baseline in Seated DBP (mmHg) at Week 12
|
-7.6 mmHg
Interval -9.5 to -5.7
|
-2.6 mmHg
Interval -4.5 to -0.7
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Patients that were randomised and treated, and with data collected at both baseline and week 12 are included in analysis.
Outcome measures
| Measure |
Baxdrostat 2 mg
n=89 Participants
Baxdrostat 2 mg
|
Placebo
n=95 Participants
Placebo
|
|---|---|---|
|
Achieving a Nocturnal SBP Dipping of >= 10% at Week 12
|
36 Participants
|
28 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 4Population: Patients that were randomised and treated, and with data collected at baseline are included in analysis.
Outcome measures
| Measure |
Baxdrostat 2 mg
n=108 Participants
Baxdrostat 2 mg
|
Placebo
n=109 Participants
Placebo
|
|---|---|---|
|
Least Square Mean Difference for Change From Baseline in Seated SBP at Week 4
|
-12.1 mmHg
Interval -14.8 to -9.4
|
-1.1 mmHg
Interval -3.8 to 1.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 8Population: Patients that were randomised and treated, and with data collected at baseline are included in analysis.
Outcome measures
| Measure |
Baxdrostat 2 mg
n=108 Participants
Baxdrostat 2 mg
|
Placebo
n=109 Participants
Placebo
|
|---|---|---|
|
Least Square Mean Difference for Change From Baseline in Seated SBP at Week 8
|
-11.6 mmHg
Interval -14.5 to -8.6
|
-2.4 mmHg
Interval -5.4 to 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 4Population: Patients that were randomised and treated, and with data collected at baseline are included in analysis.
Outcome measures
| Measure |
Baxdrostat 2 mg
n=108 Participants
Baxdrostat 2 mg
|
Placebo
n=109 Participants
Placebo
|
|---|---|---|
|
Least Square Mean Difference for Change From Baseline in Seated DBP at Week 4
|
-5.4 mmHg
Interval -7.3 to -3.6
|
0.1 mmHg
Interval -1.8 to 1.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 8Population: Patients that were randomised and treated, and with data collected at baseline are included in analysis.
Outcome measures
| Measure |
Baxdrostat 2 mg
n=108 Participants
Baxdrostat 2 mg
|
Placebo
n=109 Participants
Placebo
|
|---|---|---|
|
Least Square Mean Difference for Change From Baseline in Seated DBP at Week 8
|
-6.1 mmHg
Interval -7.8 to -4.3
|
-0.5 mmHg
Interval -2.3 to 1.2
|
Adverse Events
Baxdrostat 2 mg
Serious events: 1 serious events
Other events: 56 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Baxdrostat 2 mg
n=108 participants at risk
Baxdrostat 2 mg
|
Placebo
n=109 participants at risk
Placebo
|
|---|---|---|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
Other adverse events
| Measure |
Baxdrostat 2 mg
n=108 participants at risk
Baxdrostat 2 mg
|
Placebo
n=109 participants at risk
Placebo
|
|---|---|---|
|
Eye disorders
Myopia
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Vascular disorders
Hypertension
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
3.7%
4/109 • Number of events 4 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Vascular disorders
Hypotension
|
4.6%
5/108 • Number of events 6 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Vascular disorders
Orthostatic hypotension
|
1.9%
2/108 • Number of events 2 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Vascular disorders
Thrombophlebitis
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Eye disorders
Vision blurred
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Gastrointestinal disorders
Anal fissure
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
3/108 • Number of events 3 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
1.8%
2/109 • Number of events 2 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
General disorders
Chest pain
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
General disorders
Fatigue
|
2.8%
3/108 • Number of events 3 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
General disorders
Gravitational oedema
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
General disorders
Influenza like illness
|
2.8%
3/108 • Number of events 3 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
General disorders
Peripheral swelling
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
General disorders
Pyrexia
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
1.8%
2/109 • Number of events 2 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Immune system disorders
Seasonal allergy
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Infections and infestations
Bacteriuria
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Infections and infestations
Covid-19
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Infections and infestations
Gastroenteritis
|
1.9%
2/108 • Number of events 2 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Infections and infestations
Helicobacter gastritis
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Infections and infestations
Influenza
|
2.8%
3/108 • Number of events 3 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Infections and infestations
Paronychia
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Infections and infestations
Pneumonia
|
1.9%
2/108 • Number of events 2 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Infections and infestations
Post-acute covid-19 syndrome
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Investigations
Blood potassium increased
|
0.93%
1/108 • Number of events 2 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Infections and infestations
Skin infection
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Infections and infestations
Tonsillitis
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
2/108 • Number of events 2 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Infections and infestations
Urinary tract infection
|
2.8%
3/108 • Number of events 3 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Investigations
Alanine aminotransferase increased
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Investigations
Aspartate aminotransferase increased
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Investigations
Bilirubin urine present
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Investigations
Blood bicarbonate decreased
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Investigations
Blood creatinine increased
|
2.8%
3/108 • Number of events 4 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Investigations
Blood pressure decreased
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Investigations
Blood urea increased
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Investigations
Glomerular filtration rate decreased
|
2.8%
3/108 • Number of events 3 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Investigations
Liver function test increased
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Investigations
Renin increased
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Investigations
Sars-cov-2 test positive
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Investigations
Urinary sediment present
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.2%
11/108 • Number of events 12 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
2.8%
3/109 • Number of events 4 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Metabolism and nutrition disorders
Hyperphagia
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Cardiac disorders
Palpitations
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
4.6%
5/109 • Number of events 5 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.9%
2/108 • Number of events 2 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
1.8%
2/109 • Number of events 2 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
2.8%
3/109 • Number of events 3 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
1.8%
2/109 • Number of events 2 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 2 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Nervous system disorders
Dizziness
|
1.9%
2/108 • Number of events 2 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Nervous system disorders
Essential tremor
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Nervous system disorders
Headache
|
5.6%
6/108 • Number of events 6 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
2.8%
3/109 • Number of events 3 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Nervous system disorders
Hemiparesis
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Nervous system disorders
Presyncope
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Psychiatric disorders
Sleep disorder
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Renal and urinary disorders
Haematuria
|
2.8%
3/108 • Number of events 3 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.9%
2/108 • Number of events 3 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.93%
1/108 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.93%
1/108 • Number of events 2 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.00%
0/109 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/108 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
0.92%
1/109 • Number of events 1 • From the day of randomization until week 14, including 12 weeks double blind treatment period and 2 weeks safety follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No unpublished information may be disclosed without prior written approval from AstraZeneca.
- Publication restrictions are in place
Restriction type: OTHER