Trial Outcomes & Findings for Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients (NCT NCT02041195)
NCT ID: NCT02041195
Last Updated: 2023-08-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
99 participants
Primary outcome timeframe
Baseline
Results posted on
2023-08-07
Participant Flow
Participant milestones
| Measure |
Stage A: Setmelanotide 0.75 mg BID
Participants received setmelanotide 0.75 milligrams (mg) by subcutaneous (SC) injection twice daily (BID) for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg SC BID. Thereafter, participants received setmelanotide 2 mg once daily (QD) by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Setmelanotide 1.5 mg QD
Participants received setmelanotide 1.5 mg by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg once daily. Thereafter, participants received setmelanotide 2 mg once daily by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 0.75 mg BID
Participants received placebo matched to setmelanotide by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 1.5 mg QD
Participants received placebo matched to setmelanotide by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage B: Setmelanotide 1.5 mg QD
Participants initially received setmelanotide 1.5 mg QD and then advanced to 2 mg QD for the remainder of the 12-week treatment period. All participants self-administered the study drug.
|
Stage B: Placebo 1.5 mg QD
Participants received placebo matched to setmelanotide QD for the 12-week treatment period. All participants self-administered the study drug.
|
Stage C: Setmelanotide 2 mg QD
Participants received setmelanotide 2 mg QD for the 12-week treatment period. All participants self-administered the study drug.
|
Stage C: Placebo 2 mg QD
Participants received placebo matched to setmelanotide QD for the 12-week treatment period. All participants self-administered the study drug.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
3
|
3
|
11
|
6
|
29
|
28
|
|
Overall Study
COMPLETED
|
8
|
6
|
3
|
3
|
10
|
6
|
22
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
0
|
0
|
1
|
0
|
7
|
3
|
Reasons for withdrawal
| Measure |
Stage A: Setmelanotide 0.75 mg BID
Participants received setmelanotide 0.75 milligrams (mg) by subcutaneous (SC) injection twice daily (BID) for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg SC BID. Thereafter, participants received setmelanotide 2 mg once daily (QD) by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Setmelanotide 1.5 mg QD
Participants received setmelanotide 1.5 mg by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg once daily. Thereafter, participants received setmelanotide 2 mg once daily by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 0.75 mg BID
Participants received placebo matched to setmelanotide by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 1.5 mg QD
Participants received placebo matched to setmelanotide by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage B: Setmelanotide 1.5 mg QD
Participants initially received setmelanotide 1.5 mg QD and then advanced to 2 mg QD for the remainder of the 12-week treatment period. All participants self-administered the study drug.
|
Stage B: Placebo 1.5 mg QD
Participants received placebo matched to setmelanotide QD for the 12-week treatment period. All participants self-administered the study drug.
|
Stage C: Setmelanotide 2 mg QD
Participants received setmelanotide 2 mg QD for the 12-week treatment period. All participants self-administered the study drug.
|
Stage C: Placebo 2 mg QD
Participants received placebo matched to setmelanotide QD for the 12-week treatment period. All participants self-administered the study drug.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
4
|
3
|
|
Overall Study
Unable to comply with study visits
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients
Baseline characteristics by cohort
| Measure |
Stage A: Setmelanotide 0.75 mg BID
n=10 Participants
Participants received setmelanotide 0.75 mg by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg SC BID. Thereafter, participants received setmelanotide 2 mg QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Setmelanotide 1.5 mg QD
n=9 Participants
Participants received setmelanotide 1.5 mg by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg once daily. Thereafter, participants received setmelanotide 2 mg once daily by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 0.75 mg BID
n=3 Participants
Participants received placebo matched to setmelanotide by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 1.5 mg QD
n=3 Participants
Participants received placebo matched to setmelanotide by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage B: Setmelanotide 1.5 mg QD
n=11 Participants
Participants initially received setmelanotide 1.5 mg QD and then advanced to 2 mg QD for the remainder of the 12-week treatment period. All participants self-administered the study drug.
|
Stage B: Placebo 1.5 mg QD
n=6 Participants
Participants received placebo matched to setmelanotide QD for the 12-week treatment period. All participants self-administered the study drug.
|
Stage C: Setmelanotide 2 mg QD
n=29 Participants
Participants received setmelanotide 2 mg QD for the 12-week treatment period. All participants self-administered the study drug.
|
Stage C: Placebo 2 mg QD
n=28 Participants
Participants received placebo matched to setmelanotide QD for the 12-week treatment period. All participants self-administered the study drug.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
28 Participants
n=24 Participants
|
99 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
18 Participants
n=24 Participants
|
59 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
40 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
26 Participants
n=8 Participants
|
25 Participants
n=24 Participants
|
82 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
44 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
17 Participants
n=24 Participants
|
46 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
11 participants
n=21 Participants
|
6 participants
n=8 Participants
|
29 participants
n=8 Participants
|
28 participants
n=24 Participants
|
99 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Full Analysis Set (FAS) included all participants with a baseline and at least one post-dose efficacy observation. Data from 2 placebo groups were combined for the efficacy analysis.
Outcome measures
| Measure |
Stage A: Setmelanotide 0.75 mg BID
n=10 Participants
Participants received setmelanotide 0.75 mg by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg SC BID. Thereafter, participants received setmelanotide 2 mg QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Setmelanotide 1.5 mg QD
n=9 Participants
Participants received setmelanotide 1.5 mg by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg once daily. Thereafter, participants received setmelanotide 2 mg once daily by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo
n=6 Participants
Participants received placebo matched to setmelanotide by SC injection QD or BID for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 1.5 mg QD
Participants received placebo matched to setmelanotide by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
|---|---|---|---|---|
|
Body Weight - Stage A
|
101.7 Kilograms (kg)
Standard Error 5.09
|
101.7 Kilograms (kg)
Standard Error 4.24
|
94.5 Kilograms (kg)
Standard Error 3.85
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Participants in the FAS with available data were analyzed. Data from 2 placebo groups were combined for the efficacy analysis.
Outcome measures
| Measure |
Stage A: Setmelanotide 0.75 mg BID
n=8 Participants
Participants received setmelanotide 0.75 mg by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg SC BID. Thereafter, participants received setmelanotide 2 mg QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Setmelanotide 1.5 mg QD
n=6 Participants
Participants received setmelanotide 1.5 mg by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg once daily. Thereafter, participants received setmelanotide 2 mg once daily by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo
n=6 Participants
Participants received placebo matched to setmelanotide by SC injection QD or BID for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 1.5 mg QD
Participants received placebo matched to setmelanotide by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight at Week 12 - Stage A
|
-1.38 percent change
Interval -3.27 to 0.52
|
-0.74 percent change
Interval -2.77 to 1.28
|
2.89 percent change
Interval 0.53 to 5.25
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: Participants in the FAS were analyzed.
Outcome measures
| Measure |
Stage A: Setmelanotide 0.75 mg BID
n=11 Participants
Participants received setmelanotide 0.75 mg by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg SC BID. Thereafter, participants received setmelanotide 2 mg QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Setmelanotide 1.5 mg QD
n=6 Participants
Participants received setmelanotide 1.5 mg by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg once daily. Thereafter, participants received setmelanotide 2 mg once daily by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo
Participants received placebo matched to setmelanotide by SC injection QD or BID for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 1.5 mg QD
Participants received placebo matched to setmelanotide by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
|---|---|---|---|---|
|
Body Weight - Stage B
|
99.4 kg
Standard Error 3.51
|
93.3 kg
Standard Error 2.92
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Participants in the FAS with available data were analyzed.
Outcome measures
| Measure |
Stage A: Setmelanotide 0.75 mg BID
n=10 Participants
Participants received setmelanotide 0.75 mg by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg SC BID. Thereafter, participants received setmelanotide 2 mg QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Setmelanotide 1.5 mg QD
n=5 Participants
Participants received setmelanotide 1.5 mg by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg once daily. Thereafter, participants received setmelanotide 2 mg once daily by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo
Participants received placebo matched to setmelanotide by SC injection QD or BID for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 1.5 mg QD
Participants received placebo matched to setmelanotide by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight at Week 12 - Stage B
|
-1.29 percent change
Interval -2.47 to -0.11
|
2.28 percent change
Interval 0.68 to 3.88
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: Participants in the FAS were analyzed.
Outcome measures
| Measure |
Stage A: Setmelanotide 0.75 mg BID
n=29 Participants
Participants received setmelanotide 0.75 mg by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg SC BID. Thereafter, participants received setmelanotide 2 mg QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Setmelanotide 1.5 mg QD
n=28 Participants
Participants received setmelanotide 1.5 mg by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg once daily. Thereafter, participants received setmelanotide 2 mg once daily by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo
Participants received placebo matched to setmelanotide by SC injection QD or BID for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 1.5 mg QD
Participants received placebo matched to setmelanotide by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
|---|---|---|---|---|
|
Body Weight - Stage C
|
98.5 Kg
Standard Error 1.87
|
98.7 Kg
Standard Error 2.44
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Participants in the FAS with available data were analyzed.
Outcome measures
| Measure |
Stage A: Setmelanotide 0.75 mg BID
n=22 Participants
Participants received setmelanotide 0.75 mg by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg SC BID. Thereafter, participants received setmelanotide 2 mg QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Setmelanotide 1.5 mg QD
n=25 Participants
Participants received setmelanotide 1.5 mg by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg once daily. Thereafter, participants received setmelanotide 2 mg once daily by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo
Participants received placebo matched to setmelanotide by SC injection QD or BID for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 1.5 mg QD
Participants received placebo matched to setmelanotide by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight at Week 12 - Stage C
|
-2.28 percent change
Interval -3.32 to -1.25
|
-0.06 percent change
Interval -1.08 to 0.95
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose up to Day 114Population: Safety Population
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs that occurred after the start of study drug administration were considered TEAEs.
Outcome measures
| Measure |
Stage A: Setmelanotide 0.75 mg BID
n=10 Participants
Participants received setmelanotide 0.75 mg by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg SC BID. Thereafter, participants received setmelanotide 2 mg QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Setmelanotide 1.5 mg QD
n=9 Participants
Participants received setmelanotide 1.5 mg by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg once daily. Thereafter, participants received setmelanotide 2 mg once daily by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo
n=3 Participants
Participants received placebo matched to setmelanotide by SC injection QD or BID for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 1.5 mg QD
n=3 Participants
Participants received placebo matched to setmelanotide by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) - Stage A
|
10 Participants
|
8 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From first dose up to Day 114Population: Safety Population
An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs that occurred after the start of study drug administration were considered TEAEs.
Outcome measures
| Measure |
Stage A: Setmelanotide 0.75 mg BID
n=11 Participants
Participants received setmelanotide 0.75 mg by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg SC BID. Thereafter, participants received setmelanotide 2 mg QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Setmelanotide 1.5 mg QD
n=6 Participants
Participants received setmelanotide 1.5 mg by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg once daily. Thereafter, participants received setmelanotide 2 mg once daily by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo
Participants received placebo matched to setmelanotide by SC injection QD or BID for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 1.5 mg QD
Participants received placebo matched to setmelanotide by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
|---|---|---|---|---|
|
Number of Participants With TEAEs - Stage B
|
9 Participants
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose up to Day 114Population: Safety Population
An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs that occurred after the start of study drug administration were considered TEAEs.
Outcome measures
| Measure |
Stage A: Setmelanotide 0.75 mg BID
n=29 Participants
Participants received setmelanotide 0.75 mg by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg SC BID. Thereafter, participants received setmelanotide 2 mg QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Setmelanotide 1.5 mg QD
n=28 Participants
Participants received setmelanotide 1.5 mg by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg once daily. Thereafter, participants received setmelanotide 2 mg once daily by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo
Participants received placebo matched to setmelanotide by SC injection QD or BID for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 1.5 mg QD
Participants received placebo matched to setmelanotide by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
|---|---|---|---|---|
|
Number of Participants With TEAEs - Stage C
|
29 Participants
|
21 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 22, and 24 hours after dosing on Day 8Population: Participants in the Pharmacokinetic (PK) Evaluable Population (included all participants who received at least 1 dose of study drug, had a post-baseline observation and had evaluable plasma concentration-time profiles for setmelanotide) with available data were analyzed
Outcome measures
| Measure |
Stage A: Setmelanotide 0.75 mg BID
n=9 Participants
Participants received setmelanotide 0.75 mg by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg SC BID. Thereafter, participants received setmelanotide 2 mg QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Setmelanotide 1.5 mg QD
n=9 Participants
Participants received setmelanotide 1.5 mg by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg once daily. Thereafter, participants received setmelanotide 2 mg once daily by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo
Participants received placebo matched to setmelanotide by SC injection QD or BID for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 1.5 mg QD
Participants received placebo matched to setmelanotide by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
|---|---|---|---|---|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage A
Predose (0 hours)
|
7.24 nanograms per milliliter (ng/mL)
Standard Deviation 2.52
|
3.54 nanograms per milliliter (ng/mL)
Standard Deviation 0.949
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage A
1 hour postdose
|
9.18 nanograms per milliliter (ng/mL)
Standard Deviation 3.04
|
8.51 nanograms per milliliter (ng/mL)
Standard Deviation 3.07
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage A
2 hours postdose
|
10.8 nanograms per milliliter (ng/mL)
Standard Deviation 3.93
|
13.0 nanograms per milliliter (ng/mL)
Standard Deviation 5.75
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage A
4 hours postdose
|
13.9 nanograms per milliliter (ng/mL)
Standard Deviation 5.05
|
18.0 nanograms per milliliter (ng/mL)
Standard Deviation 6.26
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage A
6 hours postdose
|
11.8 nanograms per milliliter (ng/mL)
Standard Deviation 5.02
|
20.6 nanograms per milliliter (ng/mL)
Standard Deviation 5.27
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage A
8 hours postdose
|
9.86 nanograms per milliliter (ng/mL)
Standard Deviation 3.66
|
19.8 nanograms per milliliter (ng/mL)
Standard Deviation 3.19
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage A
10 hours postdose
|
7.48 nanograms per milliliter (ng/mL)
Standard Deviation 3.18
|
15.5 nanograms per milliliter (ng/mL)
Standard Deviation 2.46
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage A
12 hours postdose
|
6.02 nanograms per milliliter (ng/mL)
Standard Deviation 2.49
|
11.1 nanograms per milliliter (ng/mL)
Standard Deviation 1.63
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage A
14 hours postdose
|
10.6 nanograms per milliliter (ng/mL)
Standard Deviation 5.65
|
9.15 nanograms per milliliter (ng/mL)
Standard Deviation 1.29
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage A
16 hours postdose
|
13.6 nanograms per milliliter (ng/mL)
Standard Deviation 6.96
|
7.32 nanograms per milliliter (ng/mL)
Standard Deviation 1.15
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage A
20 hours postdose
|
9.26 nanograms per milliliter (ng/mL)
Standard Deviation 3.86
|
5.23 nanograms per milliliter (ng/mL)
Standard Deviation 0.991
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage A
22 hours postdose
|
7.43 nanograms per milliliter (ng/mL)
Standard Deviation 3.32
|
4.41 nanograms per milliliter (ng/mL)
Standard Deviation 0.945
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage A
24 hours postdose
|
5.74 nanograms per milliliter (ng/mL)
Standard Deviation 2.72
|
3.58 nanograms per milliliter (ng/mL)
Standard Deviation 0.900
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours after dosing on Day 8Population: The PK Evaluable Population
Outcome measures
| Measure |
Stage A: Setmelanotide 0.75 mg BID
n=12 Participants
Participants received setmelanotide 0.75 mg by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg SC BID. Thereafter, participants received setmelanotide 2 mg QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Setmelanotide 1.5 mg QD
Participants received setmelanotide 1.5 mg by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg once daily. Thereafter, participants received setmelanotide 2 mg once daily by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo
Participants received placebo matched to setmelanotide by SC injection QD or BID for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 1.5 mg QD
Participants received placebo matched to setmelanotide by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
|---|---|---|---|---|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage C
4 hours postdose
|
24.2 ng/mL
Standard Deviation 8.19
|
—
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage C
Predose (0 hours)
|
5.03 ng/mL
Standard Deviation 1.84
|
—
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage C
1 hour postdose
|
12.3 ng/mL
Standard Deviation 3.99
|
—
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage C
2 hours postdose
|
18.1 ng/mL
Standard Deviation 6.23
|
—
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage C
6 hours postdose
|
26.5 ng/mL
Standard Deviation 7.32
|
—
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage C
8 hours postdose
|
24.0 ng/mL
Standard Deviation 5.88
|
—
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage C
10 hours postdose
|
18.1 ng/mL
Standard Deviation 3.76
|
—
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage C
12 hours postdose
|
13.9 ng/mL
Standard Deviation 3.35
|
—
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage C
14 hours postdose
|
11.2 ng/mL
Standard Deviation 2.47
|
—
|
—
|
—
|
|
Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage C
24 hours postdose
|
4.74 ng/mL
Standard Deviation 1.66
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and for one 24-hour interval between Days 8 or 15Population: Participants in the FAS with available data were analyzed.
The 24-hour ABPM parameters were obtained twice once at Baseline and once during 24-hour interval between Days 8 and 15 for all participants in Stage A. Change from Baseline in ABPM parameters (systolic blood pressure \[SBP\], diastolic blood pressure \[DBP\], pulse pressure, mean arterial pressure \[MAP\]) during 24-hour interval between Days 8 and 15 is presented.
Outcome measures
| Measure |
Stage A: Setmelanotide 0.75 mg BID
n=10 Participants
Participants received setmelanotide 0.75 mg by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg SC BID. Thereafter, participants received setmelanotide 2 mg QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Setmelanotide 1.5 mg QD
n=8 Participants
Participants received setmelanotide 1.5 mg by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg once daily. Thereafter, participants received setmelanotide 2 mg once daily by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo
n=3 Participants
Participants received placebo matched to setmelanotide by SC injection QD or BID for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 1.5 mg QD
n=3 Participants
Participants received placebo matched to setmelanotide by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
|---|---|---|---|---|
|
Change From Baseline in Ambulatory Blood Pressure Monitoring (ABPM) Parameters During 24-Hour Interval Between Days 8 and 15 - Stage A
Baseline: SBP
|
121.09 millimeters of mercury (mmHg)
Standard Deviation 7.18
|
119.89 millimeters of mercury (mmHg)
Standard Deviation 10.36
|
115.31 millimeters of mercury (mmHg)
Standard Deviation 3.81
|
117.01 millimeters of mercury (mmHg)
Standard Deviation 10.09
|
|
Change From Baseline in Ambulatory Blood Pressure Monitoring (ABPM) Parameters During 24-Hour Interval Between Days 8 and 15 - Stage A
Change at 24-hour interval between Days 8 and 15: SBP
|
-4.08 millimeters of mercury (mmHg)
Standard Deviation 6.55
|
-2.23 millimeters of mercury (mmHg)
Standard Deviation 3.95
|
-0.67 millimeters of mercury (mmHg)
Standard Deviation 4.61
|
-1.08 millimeters of mercury (mmHg)
Standard Deviation 2.90
|
|
Change From Baseline in Ambulatory Blood Pressure Monitoring (ABPM) Parameters During 24-Hour Interval Between Days 8 and 15 - Stage A
Baseline: DBP
|
71.02 millimeters of mercury (mmHg)
Standard Deviation 5.03
|
73.09 millimeters of mercury (mmHg)
Standard Deviation 9.22
|
70.48 millimeters of mercury (mmHg)
Standard Deviation 1.35
|
71.08 millimeters of mercury (mmHg)
Standard Deviation 8.81
|
|
Change From Baseline in Ambulatory Blood Pressure Monitoring (ABPM) Parameters During 24-Hour Interval Between Days 8 and 15 - Stage A
Change at 24-hour interval between Days 8 and 15: DBP
|
-2.13 millimeters of mercury (mmHg)
Standard Deviation 3.93
|
-1.55 millimeters of mercury (mmHg)
Standard Deviation 2.63
|
0.58 millimeters of mercury (mmHg)
Standard Deviation 3.42
|
-1.90 millimeters of mercury (mmHg)
Standard Deviation 2.47
|
|
Change From Baseline in Ambulatory Blood Pressure Monitoring (ABPM) Parameters During 24-Hour Interval Between Days 8 and 15 - Stage A
Baseline: Pulse pressure
|
50.07 millimeters of mercury (mmHg)
Standard Deviation 4.77
|
46.79 millimeters of mercury (mmHg)
Standard Deviation 5.31
|
44.83 millimeters of mercury (mmHg)
Standard Deviation 3.20
|
45.93 millimeters of mercury (mmHg)
Standard Deviation 2.07
|
|
Change From Baseline in Ambulatory Blood Pressure Monitoring (ABPM) Parameters During 24-Hour Interval Between Days 8 and 15 - Stage A
Change at 24-hour interval between Days 8 and 15: Pulse pressure
|
-1.94 millimeters of mercury (mmHg)
Standard Deviation 3.89
|
-0.68 millimeters of mercury (mmHg)
Standard Deviation 2.32
|
-1.25 millimeters of mercury (mmHg)
Standard Deviation 3.10
|
0.82 millimeters of mercury (mmHg)
Standard Deviation 0.77
|
|
Change From Baseline in Ambulatory Blood Pressure Monitoring (ABPM) Parameters During 24-Hour Interval Between Days 8 and 15 - Stage A
Baseline: MAP
|
88.27 millimeters of mercury (mmHg)
Standard Deviation 5.50
|
89.05 millimeters of mercury (mmHg)
Standard Deviation 8.69
|
85.45 millimeters of mercury (mmHg)
Standard Deviation 2.05
|
86.85 millimeters of mercury (mmHg)
Standard Deviation 8.34
|
|
Change From Baseline in Ambulatory Blood Pressure Monitoring (ABPM) Parameters During 24-Hour Interval Between Days 8 and 15 - Stage A
Change at 24-hour interval between Days 8 and 15: MAP
|
-2.73 millimeters of mercury (mmHg)
Standard Deviation 4.42
|
-1.98 millimeters of mercury (mmHg)
Standard Deviation 2.81
|
0.44 millimeters of mercury (mmHg)
Standard Deviation 3.46
|
-1.63 millimeters of mercury (mmHg)
Standard Deviation 2.67
|
SECONDARY outcome
Timeframe: Baseline and for one 24-hour interval between Days 8 or 15Population: Participants in the FAS with available data were analyzed.
The 24-hour ABPM parameters were obtained twice once at Baseline and once during 24-hour interval between Days 8 and 15 for a subset of participants in Stage C. Change from Baseline in ABPM parameters (SBP, DBP, pulse pressure, MAP) during 24-hour interval between Days 8 and 15 is presented.
Outcome measures
| Measure |
Stage A: Setmelanotide 0.75 mg BID
n=17 Participants
Participants received setmelanotide 0.75 mg by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg SC BID. Thereafter, participants received setmelanotide 2 mg QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Setmelanotide 1.5 mg QD
n=16 Participants
Participants received setmelanotide 1.5 mg by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg once daily. Thereafter, participants received setmelanotide 2 mg once daily by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo
Participants received placebo matched to setmelanotide by SC injection QD or BID for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 1.5 mg QD
Participants received placebo matched to setmelanotide by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
|---|---|---|---|---|
|
Change From Baseline in ABPM Parameters During 24-Hour Interval Between Days 8 and 15 - Stage C
Baseline: SBP
|
117.57 mmHg
Standard Deviation 9.99
|
117.51 mmHg
Standard Deviation 8.05
|
—
|
—
|
|
Change From Baseline in ABPM Parameters During 24-Hour Interval Between Days 8 and 15 - Stage C
Change at 24-hour interval between Days 8 and 15: SBP
|
1.63 mmHg
Standard Deviation 6.83
|
1.22 mmHg
Standard Deviation 6.28
|
—
|
—
|
|
Change From Baseline in ABPM Parameters During 24-Hour Interval Between Days 8 and 15 - Stage C
Baseline: DBP
|
68.90 mmHg
Standard Deviation 7.57
|
69.92 mmHg
Standard Deviation 5.96
|
—
|
—
|
|
Change From Baseline in ABPM Parameters During 24-Hour Interval Between Days 8 and 15 - Stage C
Change at 24-hour interval between Days 8 and 15: DBP
|
1.77 mmHg
Standard Deviation 4.83
|
0.83 mmHg
Standard Deviation 4.32
|
—
|
—
|
|
Change From Baseline in ABPM Parameters During 24-Hour Interval Between Days 8 and 15 - Stage C
Baseline: Pulse pressure
|
48.67 mmHg
Standard Deviation 7.46
|
47.59 mmHg
Standard Deviation 7.58
|
—
|
—
|
|
Change From Baseline in ABPM Parameters During 24-Hour Interval Between Days 8 and 15 - Stage C
Change at 24-hour interval between Days 8 and 15: Pulse pressure
|
-0.14 mmHg
Standard Deviation 3.39
|
0.38 mmHg
Standard Deviation 2.70
|
—
|
—
|
|
Change From Baseline in ABPM Parameters During 24-Hour Interval Between Days 8 and 15 - Stage C
Baseline: MAP
|
85.97 mmHg
Standard Deviation 7.33
|
86.30 mmHg
Standard Deviation 5.23
|
—
|
—
|
|
Change From Baseline in ABPM Parameters During 24-Hour Interval Between Days 8 and 15 - Stage C
Change at 24-hour interval between Days 8 and 15: MAP
|
1.21 mmHg
Standard Deviation 5.35
|
0.68 mmHg
Standard Deviation 4.56
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and for one 24-hour interval between Days 8 and 15Population: Participants in the FAS with available data were analyzed.
The 24-hour ABPM parameters were obtained twice once at Baseline and once during 24-hour interval between Days 8 and 15 for all participants in Stage A. Change from Baseline in heart rate during 24-hour interval between Days 8 and 15 is presented.
Outcome measures
| Measure |
Stage A: Setmelanotide 0.75 mg BID
n=10 Participants
Participants received setmelanotide 0.75 mg by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg SC BID. Thereafter, participants received setmelanotide 2 mg QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Setmelanotide 1.5 mg QD
n=8 Participants
Participants received setmelanotide 1.5 mg by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg once daily. Thereafter, participants received setmelanotide 2 mg once daily by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo
n=3 Participants
Participants received placebo matched to setmelanotide by SC injection QD or BID for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 1.5 mg QD
n=3 Participants
Participants received placebo matched to setmelanotide by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
|---|---|---|---|---|
|
Change From Baseline in Heart Rate Using ABPM During 24-Hour Interval Between Days 8 and 15 - Stage A
Baseline
|
79.28 beats per minute (bpm)
Standard Deviation 7.05
|
77.55 beats per minute (bpm)
Standard Deviation 8.21
|
72.92 beats per minute (bpm)
Standard Deviation 6.80
|
68.10 beats per minute (bpm)
Standard Deviation 6.48
|
|
Change From Baseline in Heart Rate Using ABPM During 24-Hour Interval Between Days 8 and 15 - Stage A
Change at 24-hour interval between Days 8 and 15
|
-0.90 beats per minute (bpm)
Standard Deviation 3.87
|
-2.70 beats per minute (bpm)
Standard Deviation 5.38
|
-5.75 beats per minute (bpm)
Standard Deviation 7.72
|
1.35 beats per minute (bpm)
Standard Deviation 7.70
|
SECONDARY outcome
Timeframe: Baseline and for one 24-hour interval between Days 8 and 15Population: Participants in the FAS with available data were analyzed.
The 24-hour ABPM parameters were obtained twice once at Baseline and once during 24-hour interval between Days 8 and 15 for a subset of participants in Stage C. Change from Baseline in heart rate during 24-hour interval between Days 8 and 15 is presented.
Outcome measures
| Measure |
Stage A: Setmelanotide 0.75 mg BID
n=17 Participants
Participants received setmelanotide 0.75 mg by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg SC BID. Thereafter, participants received setmelanotide 2 mg QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Setmelanotide 1.5 mg QD
n=16 Participants
Participants received setmelanotide 1.5 mg by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg once daily. Thereafter, participants received setmelanotide 2 mg once daily by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo
Participants received placebo matched to setmelanotide by SC injection QD or BID for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 1.5 mg QD
Participants received placebo matched to setmelanotide by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
|---|---|---|---|---|
|
Change From Baseline in Heart Rate Using ABPM During 24-Hour Interval Between Days 8 and 15 - Stage C
Baseline
|
80.77 bpm
Standard Deviation 9.03
|
73.01 bpm
Standard Deviation 10.65
|
—
|
—
|
|
Change From Baseline in Heart Rate Using ABPM During 24-Hour Interval Between Days 8 and 15 - Stage C
Change at 24-hour interval between Days 8 and 15
|
-0.95 bpm
Standard Deviation 9.78
|
0.98 bpm
Standard Deviation 4.21
|
—
|
—
|
Adverse Events
Stage A: Setmelanotide 0.75 mg BID
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Stage A: Setmelanotide 1.5 mg QD
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Stage A: Placebo 0.75 mg BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Stage A: Placebo 1.5 mg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage B: Setmelanotide 1.5 mg QD
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Stage B: Placebo 1.5 mg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage C: Setmelanotide 2 mg QD
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Stage C: Placebo 2 mg QD
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage A: Setmelanotide 0.75 mg BID
n=10 participants at risk
Participants received setmelanotide 0.75 mg by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg SC BID. Thereafter, participants received setmelanotide 2 mg QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Setmelanotide 1.5 mg QD
n=9 participants at risk
Participants received setmelanotide 1.5 mg by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg once daily. Thereafter, participants received setmelanotide 2 mg once daily by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 0.75 mg BID
n=3 participants at risk
Participants received placebo matched to setmelanotide by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 1.5 mg QD
n=3 participants at risk
Participants received placebo matched to setmelanotide by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage B: Setmelanotide 1.5 mg QD
n=11 participants at risk
Participants initially received setmelanotide 1.5 mg QD and then advanced to 2 mg QD for the remainder of the 12-week treatment period. All participants self-administered the study drug.
|
Stage B: Placebo 1.5 mg QD
n=6 participants at risk
Participants received placebo matched to setmelanotide QD for the 12-week treatment period. All participants self-administered the study drug.
|
Stage C: Setmelanotide 2 mg QD
n=29 participants at risk
Participants received setmelanotide 2 mg QD for the 12-week treatment period. All participants self-administered the study drug.
|
Stage C: Placebo 2 mg QD
n=28 participants at risk
Participants received placebo matched to setmelanotide QD for the 12-week treatment period. All participants self-administered the study drug.
|
|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Chest pain
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
Other adverse events
| Measure |
Stage A: Setmelanotide 0.75 mg BID
n=10 participants at risk
Participants received setmelanotide 0.75 mg by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg SC BID. Thereafter, participants received setmelanotide 2 mg QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Setmelanotide 1.5 mg QD
n=9 participants at risk
Participants received setmelanotide 1.5 mg by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. During the first 4 weeks, participants were advanced to setmelanotide 2 mg once daily. Thereafter, participants received setmelanotide 2 mg once daily by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 0.75 mg BID
n=3 participants at risk
Participants received placebo matched to setmelanotide by SC injection BID for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage A: Placebo 1.5 mg QD
n=3 participants at risk
Participants received placebo matched to setmelanotide by SC injection QD for approximately 4 weeks while housed in the Phase 1 unit. Thereafter, participants received placebo matched to setmelanotide QD by SC injection for the rest of the 12-week study with drug self-administration as outpatients.
|
Stage B: Setmelanotide 1.5 mg QD
n=11 participants at risk
Participants initially received setmelanotide 1.5 mg QD and then advanced to 2 mg QD for the remainder of the 12-week treatment period. All participants self-administered the study drug.
|
Stage B: Placebo 1.5 mg QD
n=6 participants at risk
Participants received placebo matched to setmelanotide QD for the 12-week treatment period. All participants self-administered the study drug.
|
Stage C: Setmelanotide 2 mg QD
n=29 participants at risk
Participants received setmelanotide 2 mg QD for the 12-week treatment period. All participants self-administered the study drug.
|
Stage C: Placebo 2 mg QD
n=28 participants at risk
Participants received placebo matched to setmelanotide QD for the 12-week treatment period. All participants self-administered the study drug.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • From first dose up to Day 114
Safety Population
|
66.7%
6/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
54.5%
6/11 • From first dose up to Day 114
Safety Population
|
16.7%
1/6 • From first dose up to Day 114
Safety Population
|
58.6%
17/29 • From first dose up to Day 114
Safety Population
|
10.7%
3/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
44.4%
4/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
27.3%
3/11 • From first dose up to Day 114
Safety Population
|
16.7%
1/6 • From first dose up to Day 114
Safety Population
|
34.5%
10/29 • From first dose up to Day 114
Safety Population
|
10.7%
3/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
27.3%
3/11 • From first dose up to Day 114
Safety Population
|
16.7%
1/6 • From first dose up to Day 114
Safety Population
|
6.9%
2/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
70.0%
7/10 • From first dose up to Day 114
Safety Population
|
66.7%
6/9 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
72.7%
8/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
89.7%
26/29 • From first dose up to Day 114
Safety Population
|
7.1%
2/28 • From first dose up to Day 114
Safety Population
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
2/10 • From first dose up to Day 114
Safety Population
|
22.2%
2/9 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
6.9%
2/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Injection site erythema
|
20.0%
2/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
16.7%
1/6 • From first dose up to Day 114
Safety Population
|
24.1%
7/29 • From first dose up to Day 114
Safety Population
|
14.3%
4/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Fatigue
|
30.0%
3/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
34.5%
10/29 • From first dose up to Day 114
Safety Population
|
7.1%
2/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Injection site pain
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
33.3%
3/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
9.1%
1/11 • From first dose up to Day 114
Safety Population
|
16.7%
1/6 • From first dose up to Day 114
Safety Population
|
6.9%
2/29 • From first dose up to Day 114
Safety Population
|
7.1%
2/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Pain
|
20.0%
2/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
9.1%
1/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
10.3%
3/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Nervous system disorders
Headache
|
50.0%
5/10 • From first dose up to Day 114
Safety Population
|
44.4%
4/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
36.4%
4/11 • From first dose up to Day 114
Safety Population
|
33.3%
2/6 • From first dose up to Day 114
Safety Population
|
55.2%
16/29 • From first dose up to Day 114
Safety Population
|
32.1%
9/28 • From first dose up to Day 114
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
22.2%
2/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
18.2%
2/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
10.3%
3/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.0%
3/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
9.1%
1/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
20.0%
2/10 • From first dose up to Day 114
Safety Population
|
22.2%
2/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
18.2%
2/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
7.1%
2/28 • From first dose up to Day 114
Safety Population
|
|
Reproductive system and breast disorders
Spontaneous penile erection
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
33.3%
3/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
27.3%
3/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
10.3%
3/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
24.1%
7/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • From first dose up to Day 114
Safety Population
|
22.2%
2/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
33.3%
3/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
6.9%
2/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
27.3%
3/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
34.5%
10/29 • From first dose up to Day 114
Safety Population
|
14.3%
4/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Eructation
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Injection site pruritus
|
40.0%
4/10 • From first dose up to Day 114
Safety Population
|
22.2%
2/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
18.2%
2/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
17.2%
5/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Injection site swelling
|
30.0%
3/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Injection site induration
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
6.9%
2/29 • From first dose up to Day 114
Safety Population
|
7.1%
2/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Asthenia
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Axillary pain
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Feeling cold
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Injection site bruising
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Injury associated with device
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
9.1%
1/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
9.1%
1/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
10.3%
3/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
16.7%
1/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Chest pain
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
9.1%
1/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
9.1%
1/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Pyrexia
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
16.7%
1/6 • From first dose up to Day 114
Safety Population
|
6.9%
2/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
6.9%
2/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Chills
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
6.9%
2/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Feeling hot
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Injection site oedema
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Injection site scar
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Injection site warmth
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Tenderness
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Thirst
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
9.1%
1/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
6.9%
2/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Nervous system disorders
Somnolence
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Nervous system disorders
Sinus headache
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Nervous system disorders
Migraine
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
18.2%
2/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
9.1%
1/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Nervous system disorders
Lethargy
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Nervous system disorders
Parosmia
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Nervous system disorders
Post-traumatic headache
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
9.1%
1/11 • From first dose up to Day 114
Safety Population
|
16.7%
1/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
2/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
9.1%
1/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
6.9%
2/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
9.1%
1/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
6.9%
2/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
6.9%
2/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
16.7%
1/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
9.1%
1/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Reproductive system and breast disorders
Uterine spasm
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
16.7%
1/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Reproductive system and breast disorders
Vulva cyst
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
9.1%
1/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Reproductive system and breast disorders
Penile oedema
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Reproductive system and breast disorders
Vaginismus
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
18.2%
2/11 • From first dose up to Day 114
Safety Population
|
16.7%
1/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
7.1%
2/28 • From first dose up to Day 114
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Eye disorders
Eye pain
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Eye disorders
Ocular hyperaemia
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
9.1%
1/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Eye disorders
Blepharospasm
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Eye disorders
Dry eye
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Eye disorders
Eye irritation
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Eye disorders
Eye pruritus
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Eye disorders
Scleral discolouration
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
6.9%
2/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Eye disorders
Vision blurred
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Eye disorders
Eye colour change
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
9.1%
1/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Eye disorders
Ocular icterus
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
9.1%
1/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Renal and urinary disorders
Chromaturia
|
20.0%
2/10 • From first dose up to Day 114
Safety Population
|
22.2%
2/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
22.2%
2/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Renal and urinary disorders
Micturition disorder
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Renal and urinary disorders
Pyuria
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
22.2%
2/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
6.9%
2/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
10.3%
3/29 • From first dose up to Day 114
Safety Population
|
21.4%
6/28 • From first dose up to Day 114
Safety Population
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
33.3%
2/6 • From first dose up to Day 114
Safety Population
|
6.9%
2/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
16.7%
1/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Infections and infestations
Tooth infection
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
6.9%
2/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Infections and infestations
Oral herpes
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Cardiac disorders
Palpitations
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Cardiac disorders
Extrasystoles
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Psychiatric disorders
Depression
|
30.0%
3/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
11.1%
1/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
9.1%
1/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
22.2%
2/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
27.3%
3/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
34.5%
10/29 • From first dose up to Day 114
Safety Population
|
7.1%
2/28 • From first dose up to Day 114
Safety Population
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
9.1%
1/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Vascular disorders
Flushing
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
33.3%
1/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Vascular disorders
Hot flush
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Injury, poisoning and procedural complications
Muscle strain
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
16.7%
1/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
7.1%
2/28 • From first dose up to Day 114
Safety Population
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
7.1%
2/28 • From first dose up to Day 114
Safety Population
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
7.1%
2/28 • From first dose up to Day 114
Safety Population
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
10.0%
1/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Psychiatric disorders
Disturbance in sexual arousal
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
13.8%
4/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Psychiatric disorders
Logorrhoea
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
13.8%
4/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Abdominal pain lower
|
20.0%
2/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
6.9%
2/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Gingival discolouration
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
0.00%
0/29 • From first dose up to Day 114
Safety Population
|
3.6%
1/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/10 • From first dose up to Day 114
Safety Population
|
0.00%
0/9 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/3 • From first dose up to Day 114
Safety Population
|
0.00%
0/11 • From first dose up to Day 114
Safety Population
|
0.00%
0/6 • From first dose up to Day 114
Safety Population
|
3.4%
1/29 • From first dose up to Day 114
Safety Population
|
0.00%
0/28 • From first dose up to Day 114
Safety Population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place