Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension (NCT NCT00817635)
NCT ID: NCT00817635
Last Updated: 2021-06-02
Results Overview
Arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from Baseline in MSSBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and country as factors and Baseline MSSBP as a covariate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
155 participants
Primary outcome timeframe
Baseline, Week 8
Results posted on
2021-06-02
Participant Flow
Participants took part in this study at 35 investigative sites in the United States and in Iceland from 22 December 2008 to 13 October 2009.
Participants with a diagnosis of resistant hypertension were enrolled in a run-in period (Week -2 to 0). After that, the participants who fulfilled the inclusion criteria and did not meet any of the exclusion criteria at Week -2 and Week 0 were randomized to receive LCI699 or eplerenone in comparison with placebo for 8 weeks.
Participant milestones
| Measure |
LCI699 0.25 mg BID
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1 mg QD
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
26
|
31
|
33
|
33
|
|
Overall Study
COMPLETED
|
23
|
22
|
28
|
28
|
25
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
3
|
5
|
8
|
Reasons for withdrawal
| Measure |
LCI699 0.25 mg BID
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1 mg QD
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
1
|
1
|
|
Overall Study
Abnormal Laboratory Value(s)
|
1
|
1
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Administrative Problems
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
5
|
1
|
3
|
2
|
3
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension
Baseline characteristics by cohort
| Measure |
LCI699 0.25 mg BID
n=32 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1 mg QD
n=26 Participants
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
n=31 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
n=33 Participants
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
n=33 Participants
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 10.36 • n=5 Participants
|
55.4 years
STANDARD_DEVIATION 9.58 • n=7 Participants
|
57.2 years
STANDARD_DEVIATION 10.77 • n=5 Participants
|
56.2 years
STANDARD_DEVIATION 7.70 • n=4 Participants
|
59.8 years
STANDARD_DEVIATION 9.33 • n=21 Participants
|
56.5 years
STANDARD_DEVIATION 9.69 • n=8 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
58 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
97 Participants
n=8 Participants
|
|
Baseline Mean Sitting Systolic Blood Pressure (MSSBP)
|
152.4 millimeters of mercury (mmHg)
STANDARD_DEVIATION 11.21 • n=5 Participants
|
152.5 millimeters of mercury (mmHg)
STANDARD_DEVIATION 9.79 • n=7 Participants
|
152.2 millimeters of mercury (mmHg)
STANDARD_DEVIATION 7.58 • n=5 Participants
|
153.8 millimeters of mercury (mmHg)
STANDARD_DEVIATION 8.92 • n=4 Participants
|
153.4 millimeters of mercury (mmHg)
STANDARD_DEVIATION 9.61 • n=21 Participants
|
152.9 millimeters of mercury (mmHg)
STANDARD_DEVIATION 9.39 • n=8 Participants
|
|
Baseline Mean Sitting Diastolic Blood Pressure (MSDBP)
|
91.8 mmHg
STANDARD_DEVIATION 11.68 • n=5 Participants
|
89.2 mmHg
STANDARD_DEVIATION 9.56 • n=7 Participants
|
88.9 mmHg
STANDARD_DEVIATION 11.89 • n=5 Participants
|
89.1 mmHg
STANDARD_DEVIATION 9.84 • n=4 Participants
|
90.1 mmHg
STANDARD_DEVIATION 11.65 • n=21 Participants
|
89.8 mmHg
STANDARD_DEVIATION 10.92 • n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure.
Arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from Baseline in MSSBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and country as factors and Baseline MSSBP as a covariate.
Outcome measures
| Measure |
LCI699 0.25 mg BID
n=31 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1 mg QD
n=26 Participants
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
n=31 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
n=32 Participants
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
n=33 Participants
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
|---|---|---|---|---|---|
|
Change From Baseline in MSSBP at Week 8 Last Observation Carried Forward (LOCF)
|
-11.4 mmHg
Standard Error 2.96
|
-13.1 mmHg
Standard Error 3.24
|
-12.5 mmHg
Standard Error 2.96
|
-18.7 mmHg
Standard Error 2.92
|
-8.8 mmHg
Standard Error 2.87
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure.
Arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from Baseline in MSDBP was analyzed using an ANCOVA with treatment and country as factors and Baseline MSDBP as a covariate.
Outcome measures
| Measure |
LCI699 0.25 mg BID
n=31 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1 mg QD
n=26 Participants
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
n=31 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
n=32 Participants
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
n=33 Participants
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
|---|---|---|---|---|---|
|
Change From Baseline in MSDBP at Week 8 LOCF
|
-4.5 mmHg
Standard Error 1.72
|
-6.0 mmHg
Standard Error 1.88
|
-6.1 mmHg
Standard Error 1.72
|
-7.7 mmHg
Standard Error 1.69
|
-4.8 mmHg
Standard Error 1.66
|
SECONDARY outcome
Timeframe: Week 8Population: FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure.
MSSBP response was defined as the percentage of participants with a MSSBP \<140 mmHg or a \>=20 mmHg reduction from baseline reduction from baseline. MSSBP control was defined as the percentage of participants with a MSSBP \<140 mmHg for non-diabetic participants and \<130mHg for diabetic participants.
Outcome measures
| Measure |
LCI699 0.25 mg BID
n=31 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1 mg QD
n=26 Participants
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
n=31 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
n=32 Participants
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
n=33 Participants
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
|---|---|---|---|---|---|
|
Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8, as Measured by Office Blood Pressure (OBP)
MSSBP Control
|
51.6 percentage of participants
|
50.0 percentage of participants
|
32.3 percentage of participants
|
53.1 percentage of participants
|
36.4 percentage of participants
|
|
Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8, as Measured by Office Blood Pressure (OBP)
MSSBP Response
|
54.8 percentage of participants
|
57.7 percentage of participants
|
41.9 percentage of participants
|
65.6 percentage of participants
|
42.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure.
MSDBP response was defined as the percentage of participants with a MSDBP \<90 mmHg or a \>=10 mmHg reduction from baseline. MSDBP control was defined as the percentage of participants with a MSDBP \<90 mmHg for non-diabetic participants and \<80mHg for diabetic participants.
Outcome measures
| Measure |
LCI699 0.25 mg BID
n=31 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1 mg QD
n=26 Participants
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
n=31 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
n=32 Participants
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
n=33 Participants
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
|---|---|---|---|---|---|
|
Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8, as Measured by OBP
MSDBP Control
|
54.8 percentage of participants
|
65.4 percentage of participants
|
58.1 percentage of participants
|
56.3 percentage of participants
|
54.5 percentage of participants
|
|
Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8, as Measured by OBP
MSDBP Response
|
67.7 percentage of participants
|
73.1 percentage of participants
|
71.0 percentage of participants
|
71.9 percentage of participants
|
57.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure.
Arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from Baseline in MSSBP was analyzed using an ANCOVA with treatment and country as factors and Baseline MSSBP as a covariate.
Outcome measures
| Measure |
LCI699 0.25 mg BID
n=31 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1 mg QD
n=26 Participants
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
n=31 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
|---|---|---|---|---|---|
|
Dose/Exposure BP Response Relationship of LCI699, as Measured by Change From Baseline in MSSBP at Week 8
|
-11.4 mmHg
Standard Error 2.96
|
-13.1 mmHg
Standard Error 3.24
|
-12.5 mmHg
Standard Error 2.96
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure.
Arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from Baseline in MSDBP was analyzed using an ANCOVA with treatment and country as factors and Baseline MSDBP as a covariate.
Outcome measures
| Measure |
LCI699 0.25 mg BID
n=31 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1 mg QD
n=26 Participants
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
n=31 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
|---|---|---|---|---|---|
|
Dose/Exposure BP Response Relationship of LCI699, as Measured by Change From Baseline in MSDBP at Week 8
|
-4.5 mmHg
Standard Error 1.72
|
-6.0 mmHg
Standard Error 1.88
|
-6.1 mmHg
Standard Error 1.72
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure.
An ABPM measured a participant's blood pressure over a 24-hour period including daytime and nighttime readings, using an automated validated monitoring device from Baseline to Week 8. The 24-hour SBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24-hour period. The change from Baseline in SBP was analyzed using ANCOVA with treatment and country as factors and Baseline MSSBP as a covariate.
Outcome measures
| Measure |
LCI699 0.25 mg BID
n=15 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1 mg QD
n=19 Participants
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
n=26 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
n=23 Participants
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
n=23 Participants
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
|---|---|---|---|---|---|
|
Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP) at Week 8 LOCF, as Measured by Ambulatory Blood Pressure Measurement (ABPM)
Daytime Mean SBP
|
-4.9 mmHg
Standard Error 3.29
|
-6.0 mmHg
Standard Error 2.92
|
-6.3 mmHg
Standard Error 2.52
|
-15.7 mmHg
Standard Error 2.65
|
-1.6 mmHg
Standard Error 2.65
|
|
Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP) at Week 8 LOCF, as Measured by Ambulatory Blood Pressure Measurement (ABPM)
24-hour Mean SBP
|
-4.4 mmHg
Standard Error 3.22
|
-5.7 mmHg
Standard Error 2.87
|
-6.3 mmHg
Standard Error 2.47
|
-15.7 mmHg
Standard Error 2.59
|
-1.0 mmHg
Standard Error 2.59
|
|
Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP) at Week 8 LOCF, as Measured by Ambulatory Blood Pressure Measurement (ABPM)
Nighttime Mean SBP
|
-3.2 mmHg
Standard Error 3.49
|
-4.8 mmHg
Standard Error 3.13
|
-7.0 mmHg
Standard Error 2.67
|
-15.4 mmHg
Standard Error 2.81
|
0.4 mmHg
Standard Error 2.81
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure.
An ABPM measured a participant's blood pressure over a 24-hour period including daytime and nighttime readings, using an automated validated monitoring device from Baseline to Week 8. The 24-hour DBP was calculated by taking the mean of all ambulatory diastolic blood pressure readings for the 24-hour period. The change from Baseline in DBP was analyzed using an ANCOVA with treatment and country as factors and Baseline MSDBP as a covariate.
Outcome measures
| Measure |
LCI699 0.25 mg BID
n=15 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1 mg QD
n=19 Participants
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
n=26 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
n=23 Participants
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
n=23 Participants
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
|---|---|---|---|---|---|
|
Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP) at Week 8 LOCF, as Measured by ABPM
24-hour Mean DBP
|
1.0 mmHg
Standard Error 2.15
|
-3.4 mmHg
Standard Error 1.94
|
-3.7 mmHg
Standard Error 1.67
|
-9.6 mmHg
Standard Error 1.74
|
-0.2 mmHg
Standard Error 1.74
|
|
Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP) at Week 8 LOCF, as Measured by ABPM
Daytime Mean DBP
|
0.6 mmHg
Standard Error 2.31
|
-3.6 mmHg
Standard Error 2.06
|
-3.4 mmHg
Standard Error 1.78
|
-9.5 mmHg
Standard Error 1.86
|
-0.8 mmHg
Standard Error 1.87
|
|
Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP) at Week 8 LOCF, as Measured by ABPM
Nighttime Mean DBP
|
1.9 mmHg
Standard Error 2.17
|
-2.5 mmHg
Standard Error 1.98
|
-4.6 mmHg
Standard Error 1.69
|
-9.6 mmHg
Standard Error 1.75
|
1.2 mmHg
Standard Error 1.76
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure. Here, Number Analyzed 'n' represents number of participants who were evaluable for that specific category.
An ABPM measured a participant's blood pressure over a 24-hour period including daytime and nighttime readings using an automated validated monitoring device from Baseline to Week 4. The 24-hour SBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24-hour period. The change from Baseline in SBP was analyzed using an ANCOVA with treatment and country as factors and Baseline MSDBP as a covariate.
Outcome measures
| Measure |
LCI699 0.25 mg BID
n=18 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1 mg QD
n=26 Participants
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
|---|---|---|---|---|---|
|
Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime SBP in LCI699 1mg QD Versus LCI699 0.5mg BID Arm at Week 4, as Measured by ABPM
24-hour Mean SBP
|
-7.8 mmHg
Standard Error 2.72
|
-4.7 mmHg
Standard Error 2.29
|
—
|
—
|
—
|
|
Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime SBP in LCI699 1mg QD Versus LCI699 0.5mg BID Arm at Week 4, as Measured by ABPM
Daytime Mean SBP
|
-8.1 mmHg
Standard Error 2.69
|
-5.3 mmHg
Standard Error 2.27
|
—
|
—
|
—
|
|
Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime SBP in LCI699 1mg QD Versus LCI699 0.5mg BID Arm at Week 4, as Measured by ABPM
Nighttime Mean SBP
|
-6.8 mmHg
Standard Error 3.17
|
-4.5 mmHg
Standard Error 2.70
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure. Here, Number Analyzed 'n' represents number of participants who were evaluable for that specific category.
An ABPM measured a participant's blood pressure over a 24-hour period including daytime and nighttime readings using an automated validated monitoring device from Baseline to Week 4. The 24-hour DBP was calculated by taking the mean of all ambulatory diastolic blood pressure readings for the 24-hour period. The change from Baseline in DBP was analyzed using an ANCOVA with treatment and country as factors and Baseline MSDBP as a covariate.
Outcome measures
| Measure |
LCI699 0.25 mg BID
n=18 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1 mg QD
n=26 Participants
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
|---|---|---|---|---|---|
|
Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime DBP in LCI699 1mg QD Versus LCI699 0.5mg BID Arm at Week 4, as Measured by ABPM
24-hour Mean DBP
|
-4.3 mmHg
Standard Error 1.98
|
-2.5 mmHg
Standard Error 1.67
|
—
|
—
|
—
|
|
Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime DBP in LCI699 1mg QD Versus LCI699 0.5mg BID Arm at Week 4, as Measured by ABPM
Daytime Mean DBP
|
-3.9 mmHg
Standard Error 2.04
|
-2.6 mmHg
Standard Error 1.73
|
—
|
—
|
—
|
|
Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime DBP in LCI699 1mg QD Versus LCI699 0.5mg BID Arm at Week 4, as Measured by ABPM
Nighttime Mean DBP
|
-4.5 mmHg
Standard Error 2.21
|
-2.8 mmHg
Standard Error 1.87
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: AEs, Hyperkalemia, and Hyponatremia: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeksPopulation: Safety set population included all participants who were randomized and received at least 1 dose of study drug. Here, Number Analyzed represents the number of participants who were evaluable for that specific category.
An AE was an adverse medical event which occurs in a participant of the study and which is not necessarily in a causal relationship with the treatment the participant receives. SAEs were AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality. Hyperkalemia was defined as potassium level \>5.5 millimoles per liter (mmol/L). It is the medical term that describes a potassium level that's higher than normal. Hyponatremia was defined as sodium level \<135 mmol/L. It is the medical term that describes a sodium level that's lesser than normal.
Outcome measures
| Measure |
LCI699 0.25 mg BID
n=32 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1 mg QD
n=26 Participants
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
n=31 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
n=33 Participants
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
n=33 Participants
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), Hyperkalemia, and Hyponatremia
Hyperkalemia [potassium level >5.5 mmol/L]
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), Hyperkalemia, and Hyponatremia
Hyponatremia [sodium level <130 and ≥125 mmol/L]
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), Hyperkalemia, and Hyponatremia
AE(s)
|
15 Participants
|
15 Participants
|
8 Participants
|
13 Participants
|
16 Participants
|
|
Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), Hyperkalemia, and Hyponatremia
SAE(s)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), Hyperkalemia, and Hyponatremia
Hyperkalemia [potassium level ≥6.0 mmol/L]
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), Hyperkalemia, and Hyponatremia
Hyponatremia [sodium level <135 mmol/L and ≥130mmol/L]
|
3 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1-hour post-dose at Week 8Population: ACTH stimulation test subset population included all participants prior to treatment with LCI699 and at the end of the treatment interval (Week 8).
Serum cortisol concentrations at 1 hour after injection were measured to assess the maximum stimulated cortisol level achieved. Potential adrenal suppression was indicated if the serum cortisol concentration was \<500 nanomoles per liter (nmol/L) at 1 hour after the injection.
Outcome measures
| Measure |
LCI699 0.25 mg BID
n=5 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1 mg QD
n=4 Participants
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
n=6 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
n=7 Participants
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
n=7 Participants
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
|---|---|---|---|---|---|
|
Number of Participants With Cortisol Levels Below 500 Nmol/L at 1 Hour After Adrenocorticotropic Hormone (ACTH) Injection at Week 8
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure.
Percent change from Baseline was analyzed by ANCOVA model using PA values measured at Baseline and Week 8 LOCF, with treatment and country as factors and Baseline value as the covariate. Negative percent change from Baseline shows improvement.
Outcome measures
| Measure |
LCI699 0.25 mg BID
n=27 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1 mg QD
n=23 Participants
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
n=29 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
n=31 Participants
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Renin-Angiotensin-Aldosterone-System (RAAS) Biomarker: Plasma Aldosterone (PA) in LCI699 Compared to Eplerenone 50 mg at Week 8 LOCF
|
-22.3 percent change in aldosterone
Standard Error 0.16
|
-30.4 percent change in aldosterone
Standard Error 0.17
|
-53.1 percent change in aldosterone
Standard Error 0.15
|
115.0 percent change in aldosterone
Standard Error 0.15
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure.
Percent change from Baseline was analyzed by ANCOVA model using plasma renin values measured at Baseline and Week 8 LOCF, with treatment and country as factors and Baseline value as the covariate. Negative percent change from Baseline shows improvement.
Outcome measures
| Measure |
LCI699 0.25 mg BID
n=27 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1 mg QD
n=20 Participants
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
n=27 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
n=31 Participants
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in RAAS Biomarker: Plasma Renin Activity (PRA) in LCI699 Compared to Eplerenone 50mg at Week 8 LOCF
|
41.6 percent change in PRA
Standard Error 0.24
|
74.3 percent change in PRA
Standard Error 0.28
|
107.7 percent change in PRA
Standard Error 0.24
|
414.1 percent change in PRA
Standard Error 0.22
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure.
Percent change from Baseline was analyzed by ANCOVA model using active renin values measured at Baseline and Week 8 LOCF, with treatment and country as factors and Baseline value as the covariate. Negative percent change from Baseline shows improvement.
Outcome measures
| Measure |
LCI699 0.25 mg BID
n=27 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1 mg QD
n=21 Participants
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
n=28 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
n=30 Participants
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in RAAS Biomarker: Active Renin (ARC) in LCI699 Compared to Eplerenone 50mg at Week 8 LOCF
|
73.1 percent change in ARC
Standard Error 0.24
|
72.8 percent change in ARC
Standard Error 0.27
|
156.4 percent change in ARC
Standard Error 0.23
|
430.6 percent change in ARC
Standard Error 0.22
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure.
Percent change from Baseline was analyzed by ANCOVA model using percent ratio of PA to PRA values measured at Baseline and Week 8 LOCF, with treatment and country as factors and Baseline value as the covariate. Negative percent change from Baseline shows improvement.
Outcome measures
| Measure |
LCI699 0.25 mg BID
n=26 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1 mg QD
n=20 Participants
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
n=27 Participants
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
n=31 Participants
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in RAAS Biomarker: Ratio of PA to PRA in LCI699 Compared to Eplerenone 50mg at Week 8 LOCF
|
-46.7 percent change in ratio of PA to PRA
Standard Error 0.26
|
-50.0 percent change in ratio of PA to PRA
Standard Error 0.29
|
-78.3 percent change in ratio of PA to PRA
Standard Error 0.25
|
-57.1 percent change in ratio of PA to PRA
Standard Error 0.23
|
—
|
Adverse Events
LCI699 0.25 mg BID
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
LCI699 1.0 mg QD
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
LCI699 0.5 mg Followed by LCI699 1 mg BID
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Eplerenone 50 mg BID
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LCI699 0.25 mg BID
n=32 participants at risk
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1.0 mg QD
n=26 participants at risk
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
n=31 participants at risk
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
n=33 participants at risk
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
n=33 participants at risk
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
Other adverse events
| Measure |
LCI699 0.25 mg BID
n=32 participants at risk
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
|
LCI699 1.0 mg QD
n=26 participants at risk
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
|
LCI699 0.5 mg Followed by LCI699 1 mg BID
n=31 participants at risk
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
|
Eplerenone 50 mg BID
n=33 participants at risk
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
|
Placebo
n=33 participants at risk
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Inner ear inflammation
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Endocrine disorders
Goitre
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Eye disorders
Conjunctival haemorrhage
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.4%
3/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.2%
1/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.2%
1/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.2%
1/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
9.1%
3/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Oedema
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Pain
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Scratch
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.2%
1/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.2%
1/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Blood chloride increased
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Blood cortisol decreased
|
6.2%
2/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.2%
1/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
6.2%
2/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Blood glucose increased
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.2%
1/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Blood potassium increased
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Blood sodium decreased
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.2%
1/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Blood sodium increased
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Blood urea increased
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Blood uric acid increased
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.2%
1/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Glucose urine present
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.2%
1/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Heart rate irregular
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
6.5%
2/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.2%
1/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
7.7%
2/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
12.1%
4/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.2%
1/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
12.1%
4/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.2%
1/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
6.1%
2/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.2%
1/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.2%
1/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety disorder
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pyuria
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.0%
1/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
6.5%
2/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
3.1%
1/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Flushing
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.2%
1/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/32 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
3.8%
1/26 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/31 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/33 • AEs: From start of the study drug treatment up to 10 weeks; SAE: From signing of the informed consent up to 10 weeks
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER