Trial Outcomes & Findings for Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity (NCT NCT03013543)
NCT ID: NCT03013543
Last Updated: 2023-08-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
213 participants
Primary outcome timeframe
Baseline to Month 3
Results posted on
2023-08-18
Participant Flow
Of the 218 participants screened, 213 participants were enrolled in the study.
Participant milestones
| Measure |
16p11.2 Cohort
Participants with chromosomal rearrangement of the p11.2 region of chromosome 16 (16p11.2) locus causing obesity received setmelanotide once daily (QD) via subcutaneous (SC) injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
AS Cohort
Participants with Alström syndrome (AS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
BBS Cohort
Participants with Bardet-Biedl syndrome (BBS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
MC4R Cohort
Participants with melanocortin-4 receptor (MC4R) deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Heterozygous Cohort
Participants with pro-opiomelanocortin (POMC)/proprotein convertase subtilisin/kexin type 1 (PCSK1)/leptin receptor (LEPR) heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Composite Heterozygous Cohort
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Compound Heterozygous Cohort
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SH2B1 Cohort
Participants with steroid receptor coactivator (SRC) homology 2B adapter protein 1 (SH2B1) haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SMS Cohort
Participants with Smith-Magenis Syndrome (SMS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SRC1 Cohort
Participants with steroid receptor coactivator 1 (SRC1) mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
4
|
10
|
49
|
33
|
5
|
27
|
22
|
12
|
32
|
|
Overall Study
COMPLETED
|
19
|
2
|
7
|
37
|
22
|
2
|
20
|
13
|
9
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
3
|
12
|
11
|
3
|
7
|
9
|
3
|
10
|
Reasons for withdrawal
| Measure |
16p11.2 Cohort
Participants with chromosomal rearrangement of the p11.2 region of chromosome 16 (16p11.2) locus causing obesity received setmelanotide once daily (QD) via subcutaneous (SC) injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
AS Cohort
Participants with Alström syndrome (AS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
BBS Cohort
Participants with Bardet-Biedl syndrome (BBS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
MC4R Cohort
Participants with melanocortin-4 receptor (MC4R) deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Heterozygous Cohort
Participants with pro-opiomelanocortin (POMC)/proprotein convertase subtilisin/kexin type 1 (PCSK1)/leptin receptor (LEPR) heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Composite Heterozygous Cohort
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Compound Heterozygous Cohort
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SH2B1 Cohort
Participants with steroid receptor coactivator (SRC) homology 2B adapter protein 1 (SH2B1) haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SMS Cohort
Participants with Smith-Magenis Syndrome (SMS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SRC1 Cohort
Participants with steroid receptor coactivator 1 (SRC1) mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
5
|
6
|
2
|
3
|
1
|
0
|
4
|
|
Overall Study
Withdrawal By Parent/Guardian
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Other
|
0
|
0
|
2
|
0
|
2
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
3
|
2
|
1
|
3
|
8
|
0
|
2
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
2
|
|
Overall Study
Non-Compliance With Study Drug
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity
Baseline characteristics by cohort
| Measure |
16p11.2 Cohort
n=19 Participants
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
AS Cohort
n=4 Participants
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
BBS Cohort
n=10 Participants
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
MC4R Cohort
n=49 Participants
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Heterozygous Cohort
n=33 Participants
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Composite Heterozygous Cohort
n=5 Participants
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Compound Heterozygous Cohort
n=27 Participants
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SH2B1 Cohort
n=22 Participants
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SMS Cohort
n=12 Participants
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SRC1 Cohort
n=32 Participants
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
Total
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
21.4 years
STANDARD_DEVIATION 14.58 • n=99 Participants
|
16.0 years
STANDARD_DEVIATION 3.74 • n=107 Participants
|
22.5 years
STANDARD_DEVIATION 14.71 • n=206 Participants
|
22.4 years
STANDARD_DEVIATION 15.28 • n=7 Participants
|
36.1 years
STANDARD_DEVIATION 17.23 • n=31 Participants
|
40.4 years
STANDARD_DEVIATION 19.62 • n=30 Participants
|
30.7 years
STANDARD_DEVIATION 20.16 • n=3 Participants
|
33.6 years
STANDARD_DEVIATION 17.88 • n=6 Participants
|
19.4 years
STANDARD_DEVIATION 8.10 • n=114 Participants
|
31.3 years
STANDARD_DEVIATION 17.13
|
28.1 years
STANDARD_DEVIATION 17.30 • n=19 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
18 Participants
n=3 Participants
|
15 Participants
n=6 Participants
|
10 Participants
n=114 Participants
|
25 Participants
|
143 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
9 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
7 Participants
|
70 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
3 Participants
|
14 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
31 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
25 Participants
n=3 Participants
|
19 Participants
n=6 Participants
|
10 Participants
n=114 Participants
|
29 Participants
|
184 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
15 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
3 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
6 Participants
|
23 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
23 Participants
n=3 Participants
|
13 Participants
n=6 Participants
|
10 Participants
n=114 Participants
|
24 Participants
|
166 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
2 Participants
|
20 Participants
n=19 Participants
|
|
Body Weight
|
113.62 kilograms (kg)
STANDARD_DEVIATION 38.489 • n=99 Participants
|
87.28 kilograms (kg)
STANDARD_DEVIATION 16.360 • n=107 Participants
|
128.04 kilograms (kg)
STANDARD_DEVIATION 28.631 • n=206 Participants
|
117.87 kilograms (kg)
STANDARD_DEVIATION 32.339 • n=7 Participants
|
143.04 kilograms (kg)
STANDARD_DEVIATION 30.492 • n=31 Participants
|
139.05 kilograms (kg)
STANDARD_DEVIATION 30.957 • n=30 Participants
|
122.08 kilograms (kg)
STANDARD_DEVIATION 43.315 • n=3 Participants
|
129.06 kilograms (kg)
STANDARD_DEVIATION 39.480 • n=6 Participants
|
92.48 kilograms (kg)
STANDARD_DEVIATION 24.556 • n=114 Participants
|
124.07 kilograms (kg)
STANDARD_DEVIATION 33.717
|
122.98 kilograms (kg)
STANDARD_DEVIATION 36.142 • n=19 Participants
|
|
Waist Circumference
|
116.84 centimeters (cm)
STANDARD_DEVIATION 22.179 • n=99 Participants
|
109.75 centimeters (cm)
STANDARD_DEVIATION 14.523 • n=107 Participants
|
126.20 centimeters (cm)
STANDARD_DEVIATION 19.344 • n=206 Participants
|
122.52 centimeters (cm)
STANDARD_DEVIATION 19.697 • n=7 Participants
|
137.95 centimeters (cm)
STANDARD_DEVIATION 18.529 • n=31 Participants
|
134.00 centimeters (cm)
STANDARD_DEVIATION 19.038 • n=30 Participants
|
128.52 centimeters (cm)
STANDARD_DEVIATION 28.772 • n=3 Participants
|
130.28 centimeters (cm)
STANDARD_DEVIATION 23.029 • n=6 Participants
|
110.14 centimeters (cm)
STANDARD_DEVIATION 11.807 • n=114 Participants
|
123.10 centimeters (cm)
STANDARD_DEVIATION 21.101
|
125.63 centimeters (cm)
STANDARD_DEVIATION 22.162 • n=19 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 3Population: Participants in the FAS were analyzed.
Outcome measures
| Measure |
AS Cohort
n=4 Participants
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
BBS Cohort
n=10 Participants
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
MC4R Cohort
n=49 Participants
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Heterozygous Cohort
n=33 Participants
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Composite Heterozygous Cohort
n=5 Participants
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Compound Heterozygous Cohort
n=27 Participants
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
16p11.2 Cohort
n=19 Participants
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SH2B1 Cohort
n=22 Participants
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SMS Cohort
n=12 Participants
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SRC1 Cohort
n=32 Participants
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment
|
3 Participants
|
7 Participants
|
7 Participants
|
10 Participants
|
0 Participants
|
14 Participants
|
6 Participants
|
8 Participants
|
1 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From first dose up to Month 16Population: Safety Analysis Set included all participants who received at least 1 dose of study drug.
An adverse event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE (also referred to as an adverse experience) could be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TEAEs were defined as AEs reported after dosing on Day 1.
Outcome measures
| Measure |
AS Cohort
n=4 Participants
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
BBS Cohort
n=10 Participants
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
MC4R Cohort
n=49 Participants
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Heterozygous Cohort
n=33 Participants
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Composite Heterozygous Cohort
n=5 Participants
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Compound Heterozygous Cohort
n=27 Participants
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
16p11.2 Cohort
n=19 Participants
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SH2B1 Cohort
n=22 Participants
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SMS Cohort
n=12 Participants
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SRC1 Cohort
n=32 Participants
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
4 Participants
|
10 Participants
|
49 Participants
|
33 Participants
|
5 Participants
|
27 Participants
|
19 Participants
|
21 Participants
|
12 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Participants in the FAS were analyzed.
Outcome measures
| Measure |
AS Cohort
n=4 Participants
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
BBS Cohort
n=10 Participants
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
MC4R Cohort
n=49 Participants
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Heterozygous Cohort
n=33 Participants
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Composite Heterozygous Cohort
n=5 Participants
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Compound Heterozygous Cohort
n=27 Participants
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
16p11.2 Cohort
n=19 Participants
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SH2B1 Cohort
n=22 Participants
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SMS Cohort
n=12 Participants
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SRC1 Cohort
n=32 Participants
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment
|
-5.16 kg
Standard Deviation 3.860
|
-4.61 kg
Standard Deviation 7.771
|
-1.26 kg
Standard Deviation 4.851
|
-4.74 kg
Standard Deviation 7.689
|
-0.11 kg
Standard Deviation 2.432
|
-7.24 kg
Standard Deviation 6.657
|
-2.58 kg
Standard Deviation 4.886
|
-3.98 kg
Standard Deviation 5.164
|
-0.14 kg
Standard Deviation 2.805
|
-3.96 kg
Standard Deviation 4.370
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Participants in the FAS were analyzed.
Outcome measures
| Measure |
AS Cohort
n=4 Participants
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
BBS Cohort
n=10 Participants
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
MC4R Cohort
n=49 Participants
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Heterozygous Cohort
n=33 Participants
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Composite Heterozygous Cohort
n=5 Participants
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Compound Heterozygous Cohort
n=27 Participants
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
16p11.2 Cohort
n=19 Participants
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SH2B1 Cohort
n=22 Participants
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SMS Cohort
n=12 Participants
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SRC1 Cohort
n=32 Participants
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment
|
-6.38 percent change
Standard Deviation 5.043
|
-4.19 percent change
Standard Deviation 5.579
|
-0.75 percent change
Standard Deviation 4.291
|
-3.50 percent change
Standard Deviation 5.817
|
-0.31 percent change
Standard Deviation 1.772
|
-5.57 percent change
Standard Deviation 5.170
|
-2.19 percent change
Standard Deviation 3.685
|
-2.92 percent change
Standard Deviation 3.834
|
-0.00 percent change
Standard Deviation 3.651
|
-3.34 percent change
Standard Deviation 3.607
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Participants aged ≥ 12 years in the FAS with available data were analyzed.
The mean change in daily hunger questionnaire scores for participants ≥ 12 years of age with obesity in treatment with setmelanotide was evaluated. On the Daily Hunger Questionnaire, each of the 3 items (average hunger in the last 24 hours, most/worst hunger in the last 24 hours, and morning hunger) was assessed daily and scored separately using a numeric rating score for each from 0 to 10, with 0 = not hungry at all and 10 = hungriest possible.
Outcome measures
| Measure |
AS Cohort
n=4 Participants
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
BBS Cohort
n=6 Participants
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
MC4R Cohort
n=36 Participants
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Heterozygous Cohort
n=31 Participants
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Composite Heterozygous Cohort
n=4 Participants
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Compound Heterozygous Cohort
n=17 Participants
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
16p11.2 Cohort
n=14 Participants
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SH2B1 Cohort
n=19 Participants
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SMS Cohort
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SRC1 Cohort
n=29 Participants
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Baseline: Hunger Score on Average Last 24 hours
|
5.07 units on a scale
Standard Deviation 1.860
|
6.37 units on a scale
Standard Deviation 1.719
|
5.74 units on a scale
Standard Deviation 1.915
|
5.73 units on a scale
Standard Deviation 2.178
|
8.07 units on a scale
Standard Deviation 1.348
|
6.32 units on a scale
Standard Deviation 2.062
|
6.11 units on a scale
Standard Deviation 2.102
|
6.66 units on a scale
Standard Deviation 1.966
|
—
|
6.04 units on a scale
Standard Deviation 2.049
|
|
Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Change at Month 3: Hunger Score on Average Last 24 hours
|
-1.23 units on a scale
Standard Deviation 2.739
|
-3.21 units on a scale
Standard Deviation 2.858
|
-2.50 units on a scale
Standard Deviation 2.278
|
-2.71 units on a scale
Standard Deviation 1.946
|
-3.21 units on a scale
Standard Deviation 2.525
|
-3.12 units on a scale
Standard Deviation 1.911
|
-2.57 units on a scale
Standard Deviation 2.602
|
-2.78 units on a scale
Standard Deviation 2.639
|
—
|
-2.47 units on a scale
Standard Deviation 2.003
|
|
Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Baseline: Hunger Score at Most Hungry Last 24 hours
|
6.06 units on a scale
Standard Deviation 2.185
|
7.50 units on a scale
Standard Deviation 1.407
|
6.84 units on a scale
Standard Deviation 1.866
|
6.95 units on a scale
Standard Deviation 2.281
|
8.82 units on a scale
Standard Deviation 0.936
|
7.45 units on a scale
Standard Deviation 2.376
|
7.23 units on a scale
Standard Deviation 2.168
|
7.42 units on a scale
Standard Deviation 1.870
|
—
|
6.91 units on a scale
Standard Deviation 1.952
|
|
Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Change at Month 3: Hunger Score at Most Hungry Last 24 hours
|
-2.27 units on a scale
Standard Deviation 3.656
|
-4.00 units on a scale
Standard Deviation 2.717
|
-2.91 units on a scale
Standard Deviation 2.155
|
-3.00 units on a scale
Standard Deviation 2.264
|
-4.07 units on a scale
Standard Deviation 2.929
|
-3.70 units on a scale
Standard Deviation 2.501
|
-2.85 units on a scale
Standard Deviation 2.561
|
-2.68 units on a scale
Standard Deviation 2.915
|
—
|
-2.67 units on a scale
Standard Deviation 2.241
|
|
Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Baseline: Hunger Score in Morning
|
4.98 units on a scale
Standard Deviation 3.187
|
5.31 units on a scale
Standard Deviation 2.705
|
3.99 units on a scale
Standard Deviation 2.805
|
3.89 units on a scale
Standard Deviation 2.589
|
7.04 units on a scale
Standard Deviation 2.437
|
5.14 units on a scale
Standard Deviation 2.537
|
5.24 units on a scale
Standard Deviation 2.508
|
4.96 units on a scale
Standard Deviation 2.829
|
—
|
4.60 units on a scale
Standard Deviation 2.924
|
|
Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Change at Month 3: Hunger Score in Morning
|
-3.90 units on a scale
Standard Deviation 4.195
|
-3.14 units on a scale
Standard Deviation 3.173
|
-2.14 units on a scale
Standard Deviation 2.914
|
-2.85 units on a scale
Standard Deviation 2.084
|
-2.36 units on a scale
Standard Deviation 1.111
|
-3.15 units on a scale
Standard Deviation 1.781
|
-2.34 units on a scale
Standard Deviation 3.390
|
-3.09 units on a scale
Standard Deviation 1.961
|
—
|
-1.88 units on a scale
Standard Deviation 1.942
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Participants \< 12 years of age in the FAS with available data were analyzed.
The mean change in daily hunger questionnaire scores for participants \< 12 years of age with obesity in treatment with setmelanotide was evaluated. Hunger was assessed daily using a Daily Hunger Questionnaire with a pictorial (smiley face) version of the Likert rating scale with scores ranged from 0 to 4, with 0 = not hungry at all and 4 = hungriest possible.
Outcome measures
| Measure |
AS Cohort
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
BBS Cohort
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
MC4R Cohort
n=7 Participants
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Heterozygous Cohort
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Composite Heterozygous Cohort
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Compound Heterozygous Cohort
n=3 Participants
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
16p11.2 Cohort
n=4 Participants
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SH2B1 Cohort
n=3 Participants
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SMS Cohort
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SRC1 Cohort
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Baseline: Hunger Right Now
|
—
|
—
|
2.02 units on a scale
Standard Deviation 1.300
|
—
|
—
|
2.17 units on a scale
Standard Deviation 1.443
|
2.32 units on a scale
Standard Deviation 0.741
|
1.87 units on a scale
Standard Deviation 0.125
|
—
|
—
|
|
Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Change at Month 3: Hunger Right Now
|
—
|
—
|
-0.72 units on a scale
Standard Deviation 1.346
|
—
|
—
|
-1.55 units on a scale
Standard Deviation 0.910
|
-1.57 units on a scale
Standard Deviation 0.261
|
-1.44 units on a scale
Standard Deviation 0.387
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Participants ≥ 12 years of age in the FAS with available data were analyzed.
For participants ≥ 12 years of age, the following question was asked using the Global Hunger Questionnaire: Overall, how would you rate the hunger you experience now? Possible responses were: No hunger; Mild hunger; Moderate hunger; Severe hunger; and Not answered.
Outcome measures
| Measure |
AS Cohort
n=3 Participants
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
BBS Cohort
n=8 Participants
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
MC4R Cohort
n=27 Participants
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Heterozygous Cohort
n=16 Participants
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Composite Heterozygous Cohort
n=1 Participants
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Compound Heterozygous Cohort
n=17 Participants
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
16p11.2 Cohort
n=15 Participants
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SH2B1 Cohort
n=10 Participants
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SMS Cohort
n=8 Participants
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SRC1 Cohort
n=20 Participants
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
No hunger (Baseline) - Mild hunger (Month 3)
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
No hunger (Baseline) - Moderate hunger (Month 3)
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
No hunger (Baseline) - Severe hunger (Month 3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
No hunger (Baseline) - Not answered (Month 3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Mild hunger (Baseline) - No hunger (Month 3)
|
0 participants
|
0 participants
|
2 participants
|
3 participants
|
0 participants
|
2 participants
|
0 participants
|
3 participants
|
1 participants
|
4 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Mild hunger (Baseline) - Mild hunger (Month 3)
|
2 participants
|
2 participants
|
5 participants
|
0 participants
|
0 participants
|
4 participants
|
1 participants
|
0 participants
|
1 participants
|
5 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Mild hunger (Baseline) - Moderate hunger (Month 3)
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Mild hunger (Baseline) - Severe hunger (Month 3)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Mild hunger (Baseline) - Not answered (Month 3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Moderate hunger (Baseline) - No hunger (Month 3)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Moderate hunger (Baseline) - Mild hunger (Month 3)
|
0 participants
|
4 participants
|
4 participants
|
5 participants
|
1 participants
|
4 participants
|
4 participants
|
3 participants
|
1 participants
|
3 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Moderate hunger (Baseline) - Moderate hunger (Month 3)
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Moderate hunger (Baseline) - Severe hunger (Month 3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Moderate hunger (Baseline) - Not answered (Month 3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Severe hunger (Baseline) - No hunger (Month 3)
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Severe hunger (Baseline) - Mild hunger (Month 3)
|
1 participants
|
0 participants
|
5 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Severe hunger (Baseline) - Moderate hunger (Month 3)
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Severe hunger (Baseline) - Severe hunger (Month 3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Severe hunger (Baseline) - Not answered (Month 3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Not answered (Baseline) - No hunger (Month 3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Not answered (Baseline) - Mild hunger (Month 3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Not answered (Baseline) - Moderate hunger (Month 3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Not answered (Baseline) - Severe hunger (Month 3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
Not answered (Baseline) - Not answered (Month 3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
No hunger (Baseline) - No hunger (Month 3)
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Participants \< 12 years of age in the FAS with available data were analyzed.
For participants \< 12 years of age, the following question was asked to parents or caregivers of participants using the Global Hunger Questionnaire: How hungry is your child acting now? Possible responses were: Not hungry at all; A little hungry; Moderately hungry; Extremely hungry; and Not answered.
Outcome measures
| Measure |
AS Cohort
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
BBS Cohort
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
MC4R Cohort
n=7 Participants
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Heterozygous Cohort
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Composite Heterozygous Cohort
n=1 Participants
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Compound Heterozygous Cohort
n=2 Participants
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
16p11.2 Cohort
n=2 Participants
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SH2B1 Cohort
n=2 Participants
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SMS Cohort
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SRC1 Cohort
n=2 Participants
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Not hungry at all (Baseline) - Not hungry at all (Month 3)
|
—
|
—
|
1 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Not hungry at all (Baseline) - A little hungry (Month 3)
|
—
|
—
|
0 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Not hungry at all (Baseline) - Moderately hungry (Month 3)
|
—
|
—
|
0 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Not hungry at all (Baseline) - Extremely hungry (Month 3)
|
—
|
—
|
1 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Not hungry at all (Baseline) - Not answered (Month 3)
|
—
|
—
|
0 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
A little hungry (Baseline) - Not hungry at all (Month 3)
|
—
|
—
|
0 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
A little hungry (Baseline) - A little hungry (Month 3)
|
—
|
—
|
1 participants
|
—
|
1 participants
|
2 participants
|
1 participants
|
1 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
A little hungry (Baseline) - Moderately hungry (Month 3)
|
—
|
—
|
1 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
A little hungry (Baseline) - Extremely hungry (Month 3)
|
—
|
—
|
0 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
A little hungry (Baseline) - Not answered (Month 3)
|
—
|
—
|
0 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Moderately hungry (Baseline) - Not hungry at all (Month 3)
|
—
|
—
|
0 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Moderately hungry (Baseline) - A little hungry (Month 3)
|
—
|
—
|
0 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Moderately hungry (Baseline) - Moderately hungry (Month 3)
|
—
|
—
|
0 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Moderately hungry (Baseline) - Extremely hungry (Month 3)
|
—
|
—
|
0 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Moderately hungry (Baseline) - Not answered (Month 3)
|
—
|
—
|
0 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Extremely hungry (Baseline) - Not hungry at all (Month 3)
|
—
|
—
|
0 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
1 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Extremely hungry (Baseline) - A little hungry (Month 3)
|
—
|
—
|
2 participants
|
—
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
—
|
1 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Extremely hungry (Baseline) - Moderately hungry (Month 3)
|
—
|
—
|
0 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Extremely hungry (Baseline) - Extremely hungry (Month 3)
|
—
|
—
|
1 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Extremely hungry (Baseline) - Not answered (Month 3)
|
—
|
—
|
0 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Not answered (Baseline) - Not hungry at all (Month 3)
|
—
|
—
|
0 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Not answered (Baseline) - A little hungry (Month 3)
|
—
|
—
|
0 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Not answered (Baseline) - Moderately hungry (Month 3)
|
—
|
—
|
0 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Not answered (Baseline) - Extremely hungry (Month 3)
|
—
|
—
|
0 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
Not answered (Baseline) - Not answered (Month 3)
|
—
|
—
|
0 participants
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Participants in the FAS with available data were analyzed.
Waist circumference (cm) was measured according to the National Heart, Lung, and Blood Institute (NHLBI) criteria. All measurements were single measures. Waist circumference was measured when participants were in fasting condition and at approximately the same time at each visit.
Outcome measures
| Measure |
AS Cohort
n=3 Participants
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
BBS Cohort
n=9 Participants
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
MC4R Cohort
n=36 Participants
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Heterozygous Cohort
n=15 Participants
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Composite Heterozygous Cohort
n=2 Participants
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Compound Heterozygous Cohort
n=21 Participants
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
16p11.2 Cohort
n=18 Participants
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SH2B1 Cohort
n=13 Participants
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SMS Cohort
n=6 Participants
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SRC1 Cohort
n=21 Participants
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment
|
-6.60 percent change
Standard Deviation 6.828
|
-4.92 percent change
Standard Deviation 7.191
|
-0.61 percent change
Standard Deviation 11.311
|
-1.09 percent change
Standard Deviation 8.250
|
5.11 percent change
Standard Deviation 8.412
|
-5.59 percent change
Standard Deviation 6.554
|
-1.00 percent change
Standard Deviation 6.250
|
-4.91 percent change
Standard Deviation 8.495
|
-3.83 percent change
Standard Deviation 8.543
|
-2.88 percent change
Standard Deviation 4.632
|
Adverse Events
16p11.2 Cohort
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
AS Cohort
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BBS Cohort
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
MC4R Cohort
Serious events: 1 serious events
Other events: 48 other events
Deaths: 1 deaths
POMC/PCSK1/LEPR Heterozygous Cohort
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
POMC/PCSK1/LEPR Composite Heterozygous Cohort
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
POMC/PCSK1/LEPR Compound Heterozygous Cohort
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
SH2B1 Cohort
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
SMS Cohort
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
SRC1 Cohort
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
16p11.2 Cohort
n=19 participants at risk
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
AS Cohort
n=4 participants at risk
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
BBS Cohort
n=10 participants at risk
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
MC4R Cohort
n=49 participants at risk
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Heterozygous Cohort
n=33 participants at risk
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Composite Heterozygous Cohort
n=5 participants at risk
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Compound Heterozygous Cohort
n=27 participants at risk
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SH2B1 Cohort
n=22 participants at risk
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SMS Cohort
n=12 participants at risk
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SRC1 Cohort
n=32 participants at risk
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Rotavirus Infection
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic Naevus
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Typical Aura Without Headache
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
Other adverse events
| Measure |
16p11.2 Cohort
n=19 participants at risk
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
AS Cohort
n=4 participants at risk
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
BBS Cohort
n=10 participants at risk
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
MC4R Cohort
n=49 participants at risk
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Heterozygous Cohort
n=33 participants at risk
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Composite Heterozygous Cohort
n=5 participants at risk
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
POMC/PCSK1/LEPR Compound Heterozygous Cohort
n=27 participants at risk
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SH2B1 Cohort
n=22 participants at risk
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SMS Cohort
n=12 participants at risk
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
SRC1 Cohort
n=32 participants at risk
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Injection Site Pruritus
|
26.3%
5/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
50.0%
2/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
90.0%
9/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
3/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
24.2%
8/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
14.8%
4/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
2/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Injection Site Pain
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
2/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.2%
4/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
7.4%
2/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Injection Site Oedema
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
70.0%
7/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Injection Site Bruising
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
2/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
2/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Influenza Like Illness
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Injection Site Haematoma
|
10.5%
2/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
7.4%
2/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Pyrexia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Chest Pain
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Temperature Intolerance
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Injection Site Erythema
|
21.1%
4/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
60.0%
6/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.2%
4/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
24.2%
8/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
40.0%
2/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
14.8%
4/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Fatigue
|
15.8%
3/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
3/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
33.3%
11/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.9%
7/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
18.2%
4/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
12.5%
4/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Injection Site Induration
|
10.5%
2/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
50.0%
5/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
3/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
3/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Asthenia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Pain
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Feeling Cold
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Injection Site Discolouration
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Injection Site Haemorrhage
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Injection Site Hypertrophy
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Injection Site Inflammation
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Injection Site Swelling
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Peripheral Swelling
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Chest Discomfort
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Chills
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Cyst
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Feeling Jittery
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Impaired Healing
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Inflammation
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Injection Site Discomfort
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Injection Site Dryness
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Injection Site Rash
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Injection Site Warmth
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Localised Oedema
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Thirst
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Nervous system disorders
Headache
|
47.4%
9/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.4%
10/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
24.2%
8/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
48.1%
13/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
45.5%
10/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
21.9%
7/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
3/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
11.1%
3/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
2/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.4%
3/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Nervous system disorders
Migraine
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
2/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
General disorders
Injection Site Scab
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Metabolism and nutrition disorders
Abnormal Loss Of Weight
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Metabolism and nutrition disorders
Starvation Ketoacidosis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Metabolism and nutrition disorders
Vitamin B12 Deficiency
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
15.8%
3/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.2%
5/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
7.4%
2/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
2/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.1%
2/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Blood and lymphatic system disorders
White Blood Cell Disorder
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Injury, poisoning and procedural complications
Arthropod Sting
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Injury, poisoning and procedural complications
Animal Scratch
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Injury, poisoning and procedural complications
Bone Contusion
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Injury, poisoning and procedural complications
Oral Contusion
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Injury, poisoning and procedural complications
Procedural Anxiety
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Cardiac disorders
Bundle Branch Block Right
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Cardiac disorders
Tachycardia
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Cardiac disorders
Tricuspid Valve Incompetence
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Ear and labyrinth disorders
Excessive Cerumen Production
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Ear and labyrinth disorders
Middle Ear Effusion
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Renal and urinary disorders
Urine Abnormality
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Vascular disorders
Hypertension
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Vascular disorders
Haematoma
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Vascular disorders
Hypotension
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Eye disorders
Age-Related Macular Degeneration
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Eye disorders
Blepharal Pigmentation
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Eye disorders
Exophthalmos
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Eye disorders
Eye Haematoma
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Eye disorders
Eye Haemorrhage
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Eye disorders
Eye Pain
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Eye disorders
Eyelid Exfoliation
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Eye disorders
Myopia
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Eye disorders
Visual Impairment
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Endocrine disorders
Goitre
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Endocrine disorders
Hypogonadism
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Immune system disorders
Immunisation Reaction
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Congenital, familial and genetic disorders
Developmental Hip Dysplasia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Surgical and medical procedures
Cataract Operation
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Abnormal Faeces
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Coeliac Disease
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Eructation
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Gingival Hypertrophy
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Peptic Ulcer
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Pigmentation Lip
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Tooth Discolouration
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
89.5%
17/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
75.0%
3/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
80.0%
8/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
81.6%
40/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
57.6%
19/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
60.0%
3/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
77.8%
21/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
72.7%
16/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
83.3%
10/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
71.9%
23/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.1%
2/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
3/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
2/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
3/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.2%
2/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Lentigo
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
2/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
2/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Ephelides
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
2/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.2%
2/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
16.7%
2/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Nail Pigmentation
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.2%
2/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
3/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Skin Striae
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Acanthosis Nigricans
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Melanoderma
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Nail Discolouration
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Ingrowing Nail
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Lipodystrophy Acquired
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Pigmentation Disorder
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Post Inflammatory Pigmentation Change
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Skin Depigmentation
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Butterfly Rash
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Diffuse Alopecia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Hair Colour Changes
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Ingrown Hair
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Keloid Scar
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Leukoderma
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Nail Dystrophy
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Pityriasis Alba
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Skin Plaque
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Skin Sensitisation
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Solar Lentigo
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Solar Urticaria
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Urticaria Thermal
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Nausea
|
47.4%
9/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
30.0%
3/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
24.5%
12/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
42.4%
14/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
80.0%
4/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
48.1%
13/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
59.1%
13/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
16.7%
2/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
34.4%
11/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
2/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
14.3%
7/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
12.1%
4/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
40.0%
2/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
22.2%
6/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
27.3%
6/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
12.5%
4/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
2/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
14.3%
7/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
3/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
18.2%
4/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
33.3%
4/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
10.5%
2/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
2/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.2%
5/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
3/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
3/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
11.1%
3/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
13.6%
3/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.2%
2/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.1%
2/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
7.4%
2/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Nervous system disorders
Taste Disorder
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Nervous system disorders
Tremor
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
2/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Nervous system disorders
Lumbar Radiculopathy
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Nervous system disorders
Poor Quality Sleep
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Nervous system disorders
Presyncope
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Nervous system disorders
Syncope
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Nasopharyngitis
|
10.5%
2/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
3/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
15.2%
5/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
7.4%
2/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
2/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
3/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Covid-19
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
7.4%
2/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
2/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.4%
3/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Urinary Tract Infection
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
16.7%
2/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.2%
2/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
3/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
50.0%
2/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
2/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Cystitis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Fungal Infection
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Influenza
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
2/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Otitis Externa
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Paronychia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Asymptomatic Covid-19
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Bacterial Vaginosis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Candida Infection
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Conjunctivitis Bacterial
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Impetigo
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Localised Infection
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Nail Infection
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Otitis Media Acute
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Tinea Versicolour
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic Naevus
|
31.6%
6/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
2/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
28.6%
14/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
3/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
37.0%
10/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
22.7%
5/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
8/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic Naevus
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
11.1%
3/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
2/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eye Naevus
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sweat Gland Tumour
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
3/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
11.1%
3/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Alanine Aminotransferase Increased
|
10.5%
2/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
14.8%
4/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
11.1%
3/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Low Density Lipoprotein Increased
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.1%
2/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Urine Analysis Abnormal
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Blood Bilirubin Increased
|
10.5%
2/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Blood Triglycerides Increased
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.1%
2/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
C-Reactive Protein Increased
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Culture Urine Positive
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Sars-Cov-2 Test Positive
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Bilirubin Conjugated Increased
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Blood Cholesterol Abnormal
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Blood Cholesterol Increased
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Blood Lactate Dehydrogenase Decreased
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Blood Urine Present
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
C-Reactive Protein Decreased
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Coagulation Test Abnormal
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Forced Vital Capacity Decreased
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Glucose Urine Present
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
High Density Lipoprotein Decreased
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Protein Total Decreased
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Thyroid Function Test Abnormal
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Total Cholesterol/Hdl Ratio Abnormal
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Transaminases Increased
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Investigations
Urobilinogen Urine Increased
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
3/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
7.4%
2/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.1%
2/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.5%
2/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
3/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.1%
2/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.1%
2/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
7.4%
2/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's Contracture
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Pain In Jaw
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Tendon Pain
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Trigger Finger
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Psychiatric disorders
Insomnia
|
15.8%
3/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.1%
2/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
3/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
40.0%
2/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Psychiatric disorders
Libido Increased
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
3/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
2/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.4%
3/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
3/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.2%
2/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Psychiatric disorders
Libido Decreased
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.2%
2/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Psychiatric disorders
Depression
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Psychiatric disorders
Sleep Disorder
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.1%
2/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Psychiatric disorders
Terminal Insomnia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Psychiatric disorders
Abnormal Dreams
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Psychiatric disorders
Affect Lability
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Psychiatric disorders
Behaviour Disorder
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Psychiatric disorders
Mood Altered
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Psychiatric disorders
Psychological Factor Affecting Medical Condition
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Psychiatric disorders
Thinking Abnormal
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Reproductive system and breast disorders
Erection Increased
|
10.5%
2/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
14.3%
7/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
2/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
7.4%
2/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
18.2%
4/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.2%
2/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.1%
2/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Reproductive system and breast disorders
Genital Hyperaesthesia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
2/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.2%
2/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Reproductive system and breast disorders
Spontaneous Penile Erection
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
2/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Reproductive system and breast disorders
Breast Discharge
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Reproductive system and breast disorders
Breast Mass
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Reproductive system and breast disorders
Female Sexual Arousal Disorder
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Reproductive system and breast disorders
Genital Disorder Female
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Reproductive system and breast disorders
Genital Dysaesthesia
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Reproductive system and breast disorders
Labia Enlarged
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Reproductive system and breast disorders
Menstruation Irregular
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
18.2%
6/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
7.4%
2/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.2%
2/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
2/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
25.0%
1/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
10.0%
1/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
3/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
20.0%
1/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
14.8%
4/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
9.1%
2/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
5.3%
1/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.2%
4/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.1%
2/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.7%
1/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
6.1%
3/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
8.3%
1/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Metabolism and nutrition disorders
Food Craving
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
7.4%
2/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Metabolism and nutrition disorders
Glucose Tolerance Impaired
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.0%
1/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
3.1%
1/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
|
Metabolism and nutrition disorders
Impaired Fasting Glucose
|
0.00%
0/19 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/4 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/10 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
2.0%
1/49 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/33 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/5 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/27 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
4.5%
1/22 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/12 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
0.00%
0/32 • From first dose up to Month 16
Participants in the Safety Analysis Set were analyzed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All information regarding setmelanotide supplied by Rhythm to the investigator is privileged and confidential information. The investigator agrees to use this information to accomplish the study and will not use it for other purposes without consent from Rhythm. The information obtained from the clinical study will be used towards the development of setmelanotide and may be disclosed to regulatory authority(ies), other investigators, corporate partners, or consultants as required.
- Publication restrictions are in place
Restriction type: OTHER