Trial Outcomes & Findings for A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007) (NCT NCT06113328)
NCT ID: NCT06113328
Last Updated: 2026-03-17
Results Overview
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention whether or not considered related to the study intervention. The number of participants who experienced an AE is reported.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
169 participants
Primary outcome timeframe
Up to approximately 28 weeks
Results posted on
2026-03-17
Participant Flow
During the Double-Blind Treatment Period, participants received MK-6194 (3 mg every two weeks \[Q2W\] or every four weeks \[Q4W\]) or placebo, administered subcutaneously (SC). Those completing this period entered the Blinded Extension Period. Participants who received MK-6194 continued their regimen and participants who received placebo were re-randomized to MK-6194 3 mg Q2W or Q4W.
Participant milestones
| Measure |
MK-6194 3 mg Q2W
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
Participants received SC MK-6194 3 mg Q4W.
|
Placebo
Participants received SC Placebo Q2W.
|
MK-6194 3 mg Q2W (Double-blind) / MK-6194 3 mg Q2W (Extension)
After completing 24 weeks of treatment with SC MK-6194 administered 3 mg Q2W in the Double-Blind Treatment Period, participants continued to receive SC MK-6194 3 mg Q2W in the Blinded Extension Period.
|
MK-6194 3 mg Q4W (Double-blind) / MK-6194 3 mg Q4W (Extension)
After completing 24 weeks of treatment with SC MK-6194 administered 3 mg Q4W in the Double-Blind Treatment Period, participants continued to receive SC MK-6194 3 mg Q4W in the Blinded Extension Period.
|
Placebo (Double-blind)/ MK-6194 3 mg Q2W (Extension)
After completing 24 weeks of treatment with SC Placebo administered Q2W in the Double-Blind Treatment Period, participants were re-randomized to receive SC MK-6194 3 mg Q2W in the Blinded Extension Period.
|
Placebo (Double-blind)/ MK-6194 3 mg Q4W (Extension)
After completing 24 weeks of treatment with SC Placebo administered Q2W in the Double-Blind Treatment Period, participants were re-randomized to receive SC MK-6194 3 mg Q4W in the Blinded Extension Period.
|
|---|---|---|---|---|---|---|---|
|
Double-Blind Treatment Period
STARTED
|
57
|
55
|
57
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period
COMPLETED
|
34
|
45
|
53
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period
NOT COMPLETED
|
23
|
10
|
4
|
0
|
0
|
0
|
0
|
|
Blinded Extension Period
STARTED
|
0
|
0
|
0
|
34
|
43
|
27
|
26
|
|
Blinded Extension Period
COMPLETED
|
0
|
0
|
0
|
17
|
25
|
13
|
16
|
|
Blinded Extension Period
NOT COMPLETED
|
0
|
0
|
0
|
17
|
18
|
14
|
10
|
Reasons for withdrawal
| Measure |
MK-6194 3 mg Q2W
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
Participants received SC MK-6194 3 mg Q4W.
|
Placebo
Participants received SC Placebo Q2W.
|
MK-6194 3 mg Q2W (Double-blind) / MK-6194 3 mg Q2W (Extension)
After completing 24 weeks of treatment with SC MK-6194 administered 3 mg Q2W in the Double-Blind Treatment Period, participants continued to receive SC MK-6194 3 mg Q2W in the Blinded Extension Period.
|
MK-6194 3 mg Q4W (Double-blind) / MK-6194 3 mg Q4W (Extension)
After completing 24 weeks of treatment with SC MK-6194 administered 3 mg Q4W in the Double-Blind Treatment Period, participants continued to receive SC MK-6194 3 mg Q4W in the Blinded Extension Period.
|
Placebo (Double-blind)/ MK-6194 3 mg Q2W (Extension)
After completing 24 weeks of treatment with SC Placebo administered Q2W in the Double-Blind Treatment Period, participants were re-randomized to receive SC MK-6194 3 mg Q2W in the Blinded Extension Period.
|
Placebo (Double-blind)/ MK-6194 3 mg Q4W (Extension)
After completing 24 weeks of treatment with SC Placebo administered Q2W in the Double-Blind Treatment Period, participants were re-randomized to receive SC MK-6194 3 mg Q4W in the Blinded Extension Period.
|
|---|---|---|---|---|---|---|---|
|
Double-Blind Treatment Period
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period
Physician Decision
|
4
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period
Withdrawal by Subject
|
12
|
4
|
4
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period
Other
|
6
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Blinded Extension Period
Lost to Follow-up
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
|
Blinded Extension Period
Physician Decision
|
0
|
0
|
0
|
2
|
0
|
1
|
0
|
|
Blinded Extension Period
Site Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Blinded Extension Period
Study Terminated by Sponsor
|
0
|
0
|
0
|
12
|
12
|
7
|
7
|
|
Blinded Extension Period
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
3
|
4
|
1
|
|
Blinded Extension Period
Other
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
Baseline Characteristics
A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007)
Baseline characteristics by cohort
| Measure |
MK-6194 3 mg Q2W
n=57 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=55 Participants
Participants received SC MK-6194 3 mg Q4W.
|
Placebo
n=57 Participants
Participants received SC Placebo Q2W.
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.3 Years
STANDARD_DEVIATION 12.1 • n=10 Participants
|
49.9 Years
STANDARD_DEVIATION 12.0 • n=50 Participants
|
46.4 Years
STANDARD_DEVIATION 14.6 • n=108 Participants
|
47.2 Years
STANDARD_DEVIATION 13.0 • n=9 Participants
|
|
Age, Customized
Adults (between 18 and 64 years)
|
55 Participants
n=10 Participants
|
47 Participants
n=50 Participants
|
51 Participants
n=108 Participants
|
153 Participants
n=9 Participants
|
|
Age, Customized
From 65 to 84 years
|
2 Participants
n=10 Participants
|
8 Participants
n=50 Participants
|
6 Participants
n=108 Participants
|
16 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=10 Participants
|
27 Participants
n=50 Participants
|
30 Participants
n=108 Participants
|
92 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=10 Participants
|
28 Participants
n=50 Participants
|
27 Participants
n=108 Participants
|
77 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=10 Participants
|
15 Participants
n=50 Participants
|
19 Participants
n=108 Participants
|
57 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=10 Participants
|
35 Participants
n=50 Participants
|
37 Participants
n=108 Participants
|
103 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=10 Participants
|
5 Participants
n=50 Participants
|
1 Participants
n=108 Participants
|
9 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=10 Participants
|
5 Participants
n=50 Participants
|
3 Participants
n=108 Participants
|
14 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=10 Participants
|
7 Participants
n=50 Participants
|
8 Participants
n=108 Participants
|
23 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=10 Participants
|
7 Participants
n=50 Participants
|
2 Participants
n=108 Participants
|
12 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=10 Participants
|
34 Participants
n=50 Participants
|
40 Participants
n=108 Participants
|
108 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=10 Participants
|
2 Participants
n=50 Participants
|
3 Participants
n=108 Participants
|
10 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=108 Participants
|
2 Participants
n=9 Participants
|
|
Vitiligo Status (Stable vs Active)
Stable
|
29 Participants
n=10 Participants
|
28 Participants
n=50 Participants
|
30 Participants
n=108 Participants
|
87 Participants
n=9 Participants
|
|
Vitiligo Status (Stable vs Active)
Active
|
28 Participants
n=10 Participants
|
27 Participants
n=50 Participants
|
27 Participants
n=108 Participants
|
82 Participants
n=9 Participants
|
|
Previous JAK Inhibitor Exposure (Yes vs. No)
Yes
|
13 Participants
n=10 Participants
|
11 Participants
n=50 Participants
|
12 Participants
n=108 Participants
|
36 Participants
n=9 Participants
|
|
Previous JAK Inhibitor Exposure (Yes vs. No)
No
|
44 Participants
n=10 Participants
|
44 Participants
n=50 Participants
|
45 Participants
n=108 Participants
|
133 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: All randomized participants who received at least one injection of study intervention, had non-missing values at both baseline and week 24, and had available F-VASI data were analyzed.
VASI is a validated scoring method that measures the extent and severity of vitiligo depigmentation. The F-VASI measures vitiligo involvement of the facial area. For facial lesions, size is estimated using fingertip units (FTU), fingers, or thumbs: 1 FTU is approximately 0.03% body surface area (BSA), while a finger or thumb is approximately 0.1% BSA. Depigmentation at each site is graded to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. F-VASI is calculated by multiplying the area (in FTUs) by the depigmentation percentage for each facial site and summing the values. Scores range from 0 to approximately 3.5, with higher scores indicating greater vitiligo involvement of the facial area (more severe depigmentation). Percent change from baseline calculated as post-baseline value minus baseline value, divided by baseline value and multiplied by 100%. Longitudinal data analysis (LDA) model-based least squares mean (LSM) percent change from baseline to Week 24 was reported.
Outcome measures
| Measure |
MK-6194 3 mg Q2W
n=57 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=55 Participants
Participants received SC MK-6194 3 mg Q4W.
|
Placebo
n=57 Participants
Participants received SC Placebo Q2W.
|
|---|---|---|---|
|
Percent Change From Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24
|
-4.55 Percent change
Interval -16.79 to 7.68
|
-12.13 Percent change
Interval -24.29 to 0.03
|
-4.01 Percent change
Interval -15.7 to 7.69
|
PRIMARY outcome
Timeframe: Up to approximately 28 weeksPopulation: All randomized participants who received at least one injection of study intervention.
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention whether or not considered related to the study intervention. The number of participants who experienced an AE is reported.
Outcome measures
| Measure |
MK-6194 3 mg Q2W
n=57 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=55 Participants
Participants received SC MK-6194 3 mg Q4W.
|
Placebo
n=57 Participants
Participants received SC Placebo Q2W.
|
|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
51 Participants
|
47 Participants
|
44 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 24 weeksPopulation: All randomized participants who received at least one injection of study intervention.
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE is reported here.
Outcome measures
| Measure |
MK-6194 3 mg Q2W
n=57 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=55 Participants
Participants received SC MK-6194 3 mg Q4W.
|
Placebo
n=57 Participants
Participants received SC Placebo Q2W.
|
|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an AE
|
9 Participants
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All randomized participants who received at least one injection of study intervention, had non-missing values at both baseline and week 24, and had available T-VASI data were analyzed.
T-VASI is a validated scoring method that measures the extent and severity of vitiligo across the entire body. The body is divided into six regions: head/neck, hands, upper extremities, trunk, lower extremities, and feet. One hand unit (palm and fingers together) represents 1% of BSA. Depigmentation for each region is graded to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. For regions with multiple lesions, percentages are averaged. The T-VASI score is calculated by multiplying the area (in hand units) by the depigmentation percentage for each region and summing all regions. Scores range from 0 to 100, with 0 indicating no vitiligo and 100 indicating complete body involvement. Percent change from baseline calculated as post-baseline value minus baseline value, divided by baseline value and multiplied by 100%. LDA model-based LSM percent change from baseline to Week 24 was reported.
Outcome measures
| Measure |
MK-6194 3 mg Q2W
n=56 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=54 Participants
Participants received SC MK-6194 3 mg Q4W.
|
Placebo
n=57 Participants
Participants received SC Placebo Q2W.
|
|---|---|---|---|
|
Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24
|
-1.69 Percent Change
Interval -11.02 to 7.65
|
-9.08 Percent Change
Interval -18.24 to 0.08
|
0.78 Percent Change
Interval -7.77 to 9.34
|
Adverse Events
MK-6194 3 mg Q2W
Serious events: 3 serious events
Other events: 48 other events
Deaths: 0 deaths
MK-6194 3 mg Q4W
Serious events: 3 serious events
Other events: 43 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
MK-6194 3 mg Q2W (Double-blind) / MK-6194 3 mg Q2W (Extension)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
MK-6194 3 mg Q4W (Double-blind) / MK-6194 3 mg Q4W (Extension)
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo (Double-blind) / MK-6194 3 mg Q2W (Extension)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo (Double-blind) / MK-6194 3 mg Q4W (Extension)
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-6194 3 mg Q2W
n=57 participants at risk
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=55 participants at risk
Participants received SC MK-6194 3 mg Q4W.
|
Placebo
n=57 participants at risk
Participants received SC Placebo Q2W.
|
MK-6194 3 mg Q2W (Double-blind) / MK-6194 3 mg Q2W (Extension)
n=34 participants at risk
After completing 24 weeks of treatment with SC MK-6194 administered 3 mg Q2W in the Double-Blind Treatment Period, participants continued to receive SC MK-6194 3 mg Q2W in the Blinded Extension Period.
|
MK-6194 3 mg Q4W (Double-blind) / MK-6194 3 mg Q4W (Extension)
n=43 participants at risk
After completing 24 weeks of treatment with SC MK-6194 administered 3 mg Q4W in the Double-Blind Treatment Period, participants continued to receive SC MK-6194 3 mg Q4W in the Blinded Extension Period.
|
Placebo (Double-blind) / MK-6194 3 mg Q2W (Extension)
n=27 participants at risk
After completing 24 weeks of treatment with SC Placebo administered Q2W in the Double-Blind Treatment Period, participants were re-randomized to receive SC MK-6194 3 mg Q2W in the Blinded Extension Period.
|
Placebo (Double-blind) / MK-6194 3 mg Q4W (Extension)
n=26 participants at risk
After completing 24 weeks of treatment with SC Placebo administered Q2W in the Double-Blind Treatment Period, participants were re-randomized to receive SC MK-6194 3 mg Q4W in the Blinded Extension Period.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/55 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/43 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
General disorders
Injection site rash
|
1.8%
1/57 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/55 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/43 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/55 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/43 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/55 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/43 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.8%
1/26 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/55 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/43 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Investigations
Hepatic enzyme increased
|
1.8%
1/57 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/55 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/43 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.8%
1/57 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/55 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/43 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
Other adverse events
| Measure |
MK-6194 3 mg Q2W
n=57 participants at risk
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=55 participants at risk
Participants received SC MK-6194 3 mg Q4W.
|
Placebo
n=57 participants at risk
Participants received SC Placebo Q2W.
|
MK-6194 3 mg Q2W (Double-blind) / MK-6194 3 mg Q2W (Extension)
n=34 participants at risk
After completing 24 weeks of treatment with SC MK-6194 administered 3 mg Q2W in the Double-Blind Treatment Period, participants continued to receive SC MK-6194 3 mg Q2W in the Blinded Extension Period.
|
MK-6194 3 mg Q4W (Double-blind) / MK-6194 3 mg Q4W (Extension)
n=43 participants at risk
After completing 24 weeks of treatment with SC MK-6194 administered 3 mg Q4W in the Double-Blind Treatment Period, participants continued to receive SC MK-6194 3 mg Q4W in the Blinded Extension Period.
|
Placebo (Double-blind) / MK-6194 3 mg Q2W (Extension)
n=27 participants at risk
After completing 24 weeks of treatment with SC Placebo administered Q2W in the Double-Blind Treatment Period, participants were re-randomized to receive SC MK-6194 3 mg Q2W in the Blinded Extension Period.
|
Placebo (Double-blind) / MK-6194 3 mg Q4W (Extension)
n=26 participants at risk
After completing 24 weeks of treatment with SC Placebo administered Q2W in the Double-Blind Treatment Period, participants were re-randomized to receive SC MK-6194 3 mg Q4W in the Blinded Extension Period.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
7.0%
4/57 • Number of events 4 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
5.5%
3/55 • Number of events 6 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/57 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
2.3%
1/43 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
11.5%
3/26 • Number of events 7 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.5%
2/57 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.3%
4/55 • Number of events 4 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/43 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
2/57 • Number of events 3 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.6%
2/55 • Number of events 7 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.0%
4/57 • Number of events 6 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
2.3%
1/43 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.7%
1/27 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.7%
2/26 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
3/57 • Number of events 5 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.3%
4/55 • Number of events 4 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.0%
4/57 • Number of events 7 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/43 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.8%
1/26 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
General disorders
Fatigue
|
7.0%
4/57 • Number of events 6 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/55 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/57 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/43 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.4%
2/27 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
General disorders
Influenza like illness
|
3.5%
2/57 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/55 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
5.3%
3/57 • Number of events 6 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
4.7%
2/43 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.7%
2/26 • Number of events 3 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
General disorders
Injection site bruising
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
5.5%
3/55 • Number of events 4 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
2.3%
1/43 • Number of events 7 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.7%
1/27 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
General disorders
Injection site rash
|
3.5%
2/57 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.3%
4/55 • Number of events 5 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
2.3%
1/43 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.7%
1/27 • Number of events 4 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
11.5%
3/26 • Number of events 3 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
General disorders
Injection site erythema
|
33.3%
19/57 • Number of events 54 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
41.8%
23/55 • Number of events 46 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/57 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
14.7%
5/34 • Number of events 18 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
30.2%
13/43 • Number of events 46 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.4%
2/27 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
23.1%
6/26 • Number of events 14 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
General disorders
Injection site hypersensitivity
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/55 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/43 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
11.1%
3/27 • Number of events 3 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
General disorders
Injection site induration
|
3.5%
2/57 • Number of events 4 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
9.1%
5/55 • Number of events 9 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
2.9%
1/34 • Number of events 4 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.0%
3/43 • Number of events 7 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
11.5%
3/26 • Number of events 7 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
General disorders
Injection site pain
|
3.5%
2/57 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
12.7%
7/55 • Number of events 9 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.5%
2/57 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.0%
3/43 • Number of events 5 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.8%
1/26 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
General disorders
Injection site pruritus
|
15.8%
9/57 • Number of events 27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
10.9%
6/55 • Number of events 10 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/57 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
5.9%
2/34 • Number of events 9 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
16.3%
7/43 • Number of events 18 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.7%
1/27 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
11.5%
3/26 • Number of events 8 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
General disorders
Injection site reaction
|
31.6%
18/57 • Number of events 70 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
21.8%
12/55 • Number of events 34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/57 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
23.5%
8/34 • Number of events 33 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
18.6%
8/43 • Number of events 22 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
14.8%
4/27 • Number of events 15 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
46.2%
12/26 • Number of events 34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
General disorders
Injection site swelling
|
5.3%
3/57 • Number of events 9 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
9.1%
5/55 • Number of events 10 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
5.9%
2/34 • Number of events 5 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
14.0%
6/43 • Number of events 17 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
General disorders
Injection site urticaria
|
1.8%
1/57 • Number of events 3 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/55 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/43 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.4%
2/27 • Number of events 6 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Infections and infestations
COVID-19
|
5.3%
3/57 • Number of events 3 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/55 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
8.8%
5/57 • Number of events 5 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/43 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.8%
1/26 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Infections and infestations
Conjunctivitis
|
3.5%
2/57 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/55 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/57 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/43 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.7%
2/26 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Infections and infestations
Gastroenteritis
|
1.8%
1/57 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/55 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
5.3%
3/57 • Number of events 3 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
2.3%
1/43 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Infections and infestations
Influenza
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.3%
4/55 • Number of events 4 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/57 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
2.9%
1/34 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
4.7%
2/43 • Number of events 3 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
5/57 • Number of events 6 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/55 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
22.8%
13/57 • Number of events 14 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
11.6%
5/43 • Number of events 5 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
11.1%
3/27 • Number of events 4 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.8%
1/26 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.5%
2/57 • Number of events 3 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.6%
2/55 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
5.3%
3/57 • Number of events 3 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
2.3%
1/43 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Infections and infestations
Urinary tract infection
|
5.3%
3/57 • Number of events 3 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/55 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/57 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/43 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.8%
1/26 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
3.5%
2/57 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.6%
2/55 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
5.3%
3/57 • Number of events 4 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
5.9%
2/34 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
11.6%
5/43 • Number of events 5 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.7%
1/27 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
11.5%
3/26 • Number of events 5 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Nervous system disorders
Headache
|
17.5%
10/57 • Number of events 15 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
14.5%
8/55 • Number of events 10 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
5.3%
3/57 • Number of events 5 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
2.3%
1/43 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
3/57 • Number of events 3 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/55 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/57 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/43 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Investigations
Eosinophil count increased
|
12.3%
7/57 • Number of events 10 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.3%
4/55 • Number of events 5 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
5.9%
2/34 • Number of events 3 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
9.3%
4/43 • Number of events 5 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.7%
1/27 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.8%
1/26 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.0%
8/57 • Number of events 12 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.3%
4/55 • Number of events 6 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.0%
4/57 • Number of events 4 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
2.9%
1/34 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
4.7%
2/43 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/55 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
5.3%
3/57 • Number of events 4 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
2.9%
1/34 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
2.3%
1/43 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.4%
2/27 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.8%
5/57 • Number of events 5 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
5.5%
3/55 • Number of events 4 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/57 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
2.3%
1/43 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
1/57 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
5.5%
3/55 • Number of events 3 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/43 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
3/57 • Number of events 3 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/55 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/57 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
2.9%
1/34 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/43 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.5%
2/57 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/55 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
5.9%
2/34 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
2.3%
1/43 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.4%
2/27 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.5%
2/57 • Number of events 3 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/55 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/57 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
2.9%
1/34 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
4.7%
2/43 • Number of events 4 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.4%
2/27 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/26 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.8%
5/57 • Number of events 6 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.6%
2/55 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.5%
2/57 • Number of events 5 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
2.9%
1/34 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.0%
3/43 • Number of events 5 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
14.8%
4/27 • Number of events 8 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.8%
1/26 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.8%
5/57 • Number of events 5 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.6%
2/55 • Number of events 3 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
8.8%
5/57 • Number of events 5 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/34 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
2.3%
1/43 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/27 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
7.7%
2/26 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.5%
2/57 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
1.8%
1/55 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/57 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
5.9%
2/34 • Number of events 2 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
0.00%
0/43 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
11.1%
3/27 • Number of events 3 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
3.8%
1/26 • Number of events 1 • Up to approximately 61 weeks
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants according to treatment received.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER