Trial Outcomes & Findings for A Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity (NCT NCT06854952)
NCT ID: NCT06854952
Last Updated: 2026-08-10
Results Overview
Percent change (%) in body weight from baseline to Week 12
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
167 participants
Primary outcome timeframe
12 weeks
Results posted on
2026-08-10
Participant Flow
Participant milestones
| Measure |
TERN-601 250 mg
Orally administered once daily.
|
TERN-601 500 mg (Slow Titration)
Orally administered once daily.
|
TERN-601 500 mg
Orally administered once daily.
|
TERN-601 750 mg
Orally administered once daily.
|
Matching Placebo
Orally administered once daily.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
34
|
34
|
33
|
33
|
|
Overall Study
COMPLETED
|
24
|
28
|
28
|
29
|
27
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
6
|
4
|
6
|
Reasons for withdrawal
| Measure |
TERN-601 250 mg
Orally administered once daily.
|
TERN-601 500 mg (Slow Titration)
Orally administered once daily.
|
TERN-601 500 mg
Orally administered once daily.
|
TERN-601 750 mg
Orally administered once daily.
|
Matching Placebo
Orally administered once daily.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
2
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
1
|
3
|
|
Overall Study
Investigator Discretion
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
1
|
1
|
1
|
|
Overall Study
Prohibited Medication
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Other: SUBJECT WAS DISCONTINUED DUE TO POSITIVE URINE DRUG SCREEN PER SPONSOR GUIDANCE
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Other: WITHDRAWN FROM STUDY DUE TO +DRUG TEST
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity
Baseline characteristics by cohort
| Measure |
TERN-601 250 mg
n=33 Participants
Orally administered once daily.
|
TERN-601 500 mg (Slow Titration)
n=34 Participants
Orally administered once daily.
|
TERN-601 500 mg
n=34 Participants
Orally administered once daily.
|
TERN-601 750 mg
n=33 Participants
Orally administered once daily.
|
Matching Placebo
n=33 Participants
Orally administered once daily.
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=120 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=54 Participants
|
31 Participants
n=54 Participants
|
29 Participants
n=27 Participants
|
29 Participants
n=26 Participants
|
29 Participants
n=161 Participants
|
146 Participants
n=120 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=54 Participants
|
3 Participants
n=54 Participants
|
5 Participants
n=27 Participants
|
4 Participants
n=26 Participants
|
4 Participants
n=161 Participants
|
21 Participants
n=120 Participants
|
|
Age, Continuous
|
47.6 Years
STANDARD_DEVIATION 15.87 • n=54 Participants
|
48.1 Years
STANDARD_DEVIATION 13.33 • n=54 Participants
|
53.6 Years
STANDARD_DEVIATION 11.43 • n=27 Participants
|
50.5 Years
STANDARD_DEVIATION 13.82 • n=26 Participants
|
51.2 Years
STANDARD_DEVIATION 12.93 • n=161 Participants
|
50.2 Years
STANDARD_DEVIATION 13.56 • n=120 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=54 Participants
|
27 Participants
n=54 Participants
|
27 Participants
n=27 Participants
|
26 Participants
n=26 Participants
|
26 Participants
n=161 Participants
|
132 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=54 Participants
|
7 Participants
n=54 Participants
|
7 Participants
n=27 Participants
|
7 Participants
n=26 Participants
|
7 Participants
n=161 Participants
|
35 Participants
n=120 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=54 Participants
|
2 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
3 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
1 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=54 Participants
|
5 Participants
n=54 Participants
|
10 Participants
n=27 Participants
|
10 Participants
n=26 Participants
|
8 Participants
n=161 Participants
|
38 Participants
n=120 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=54 Participants
|
26 Participants
n=54 Participants
|
23 Participants
n=27 Participants
|
22 Participants
n=26 Participants
|
24 Participants
n=161 Participants
|
121 Participants
n=120 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=26 Participants
|
1 Participants
n=161 Participants
|
4 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=54 Participants
|
7 Participants
n=54 Participants
|
11 Participants
n=27 Participants
|
9 Participants
n=26 Participants
|
11 Participants
n=161 Participants
|
47 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=54 Participants
|
27 Participants
n=54 Participants
|
23 Participants
n=27 Participants
|
24 Participants
n=26 Participants
|
22 Participants
n=161 Participants
|
120 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=120 Participants
|
|
Weight (kg)
|
99.63 kg
STANDARD_DEVIATION 18.643 • n=54 Participants
|
99.46 kg
STANDARD_DEVIATION 16.690 • n=54 Participants
|
100.22 kg
STANDARD_DEVIATION 16.702 • n=27 Participants
|
101.84 kg
STANDARD_DEVIATION 18.359 • n=26 Participants
|
99.68 kg
STANDARD_DEVIATION 20.768 • n=161 Participants
|
101.16 kg
STANDARD_DEVIATION 18.075 • n=120 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Intent-to-treat population.
Percent change (%) in body weight from baseline to Week 12
Outcome measures
| Measure |
TERN-601 250 mg
n=27 Participants
Orally administered once daily.
|
TERN-601 500 mg (Slow Titration)
n=28 Participants
Orally administered once daily.
|
TERN-601 500 mg
n=28 Participants
Orally administered once daily.
|
TERN-601 750 mg
n=28 Participants
Orally administered once daily.
|
Matching Placebo
n=26 Participants
Orally administered once daily.
|
|---|---|---|---|---|---|
|
Percent Change in Body Weight
|
-2.11 Percent Change (%)
Standard Error 0.688
|
-3.85 Percent Change (%)
Standard Error 0.687
|
-4.87 Percent Change (%)
Standard Error 0.688
|
-3.31 Percent Change (%)
Standard Error 0.688
|
-0.30 Percent Change (%)
Standard Error 0.701
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent-to-treat population.
Change in body weight (kg) from baseline to Week 12
Outcome measures
| Measure |
TERN-601 250 mg
n=27 Participants
Orally administered once daily.
|
TERN-601 500 mg (Slow Titration)
n=28 Participants
Orally administered once daily.
|
TERN-601 500 mg
n=28 Participants
Orally administered once daily.
|
TERN-601 750 mg
n=28 Participants
Orally administered once daily.
|
Matching Placebo
n=26 Participants
Orally administered once daily.
|
|---|---|---|---|---|---|
|
Change in Body Weight (kg)
|
-2.23 kg
Standard Error 0.733
|
-4.02 kg
Standard Error 0.735
|
-4.97 kg
Standard Error 0.735
|
-3.60 kg
Standard Error 0.740
|
-0.45 kg
Standard Error 0.746
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent-to-treat population.
Participants achieving ≥ 5% weight loss
Outcome measures
| Measure |
TERN-601 250 mg
n=27 Participants
Orally administered once daily.
|
TERN-601 500 mg (Slow Titration)
n=28 Participants
Orally administered once daily.
|
TERN-601 500 mg
n=28 Participants
Orally administered once daily.
|
TERN-601 750 mg
n=28 Participants
Orally administered once daily.
|
Matching Placebo
n=26 Participants
Orally administered once daily.
|
|---|---|---|---|---|---|
|
≥ 5% Weight Loss
|
4 Participants
Interval 5.2 to 30.8
|
11 Participants
Interval 23.8 to 56.5
|
13 Participants
Interval 30.1 to 63.4
|
7 Participants
Interval 12.4 to 41.9
|
4 Participants
Interval 5.4 to 31.8
|
Adverse Events
TERN-601 250 mg
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
TERN-601 500 mg (Slow Titration)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
TERN-601 500 mg
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
TERN-601 750 mg
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TERN-601 250 mg
n=33 participants at risk
Orally administered once daily.
|
TERN-601 500 mg (Slow Titration)
n=34 participants at risk
Orally administered once daily.
|
TERN-601 500 mg
n=34 participants at risk
Orally administered once daily.
|
TERN-601 750 mg
n=33 participants at risk
Orally administered once daily.
|
Matching Placebo
n=33 participants at risk
Orally administered once daily.
|
|---|---|---|---|---|---|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
TERN-601 250 mg
n=33 participants at risk
Orally administered once daily.
|
TERN-601 500 mg (Slow Titration)
n=34 participants at risk
Orally administered once daily.
|
TERN-601 500 mg
n=34 participants at risk
Orally administered once daily.
|
TERN-601 750 mg
n=33 participants at risk
Orally administered once daily.
|
Matching Placebo
n=33 participants at risk
Orally administered once daily.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
8.8%
3/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
20.6%
7/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
6.1%
2/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
12.1%
4/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
8.8%
3/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
6.1%
2/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Nervous system disorders
Tension headache
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
8.8%
3/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
8.8%
3/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
6.1%
2/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
General disorders
Drug intolerance
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
General disorders
Feeling jittery
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
5.9%
2/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
5.9%
2/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Infections and infestations
Ear infection
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Infections and infestations
Otitis externa
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
6.1%
2/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.1%
4/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
11.8%
4/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
11.8%
4/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
6.1%
2/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
2/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
8.8%
3/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
9.1%
3/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
6.1%
2/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Eructation
|
9.1%
3/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
8.8%
3/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
5.9%
2/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
6.1%
2/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.1%
2/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
6.1%
2/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
48.5%
16/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
50.0%
17/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
64.7%
22/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
60.6%
20/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
9.1%
3/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
2/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
29.4%
10/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
38.2%
13/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
33.3%
11/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
6.1%
2/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
5.9%
2/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
23.5%
8/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
12.1%
4/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.1%
2/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
5.9%
2/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Dental restoration failure
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Investigations
Electrocardiogram QRS complex abnormal
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
2.9%
1/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Cervix enlargement
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/34 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
0.00%
0/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
3.0%
1/33 • From enrollment until end of follow-up (Week 16)
Adverse events are reported for participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place