Trial Outcomes & Findings for A Study of LY2951742 (Galcanezumab) in Japanese Participants With Migraine (NCT NCT02959190)
NCT ID: NCT02959190
Last Updated: 2020-09-29
Results Overview
A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
311 participants
Primary outcome timeframe
Up To 16 Months
Results posted on
2020-09-29
Participant Flow
Episodic migraine (EM) participants rolled over from parental Study I5Q-JE-CGAN (CGAN - NCT02959177)), and chronic migraine (CM) participants were newly enrolled in this CGAP study.
Participant milestones
| Measure |
120 mg Galcanezumab EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by subcutaneous (SC) injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab or placebo. Participants did not receive any intervention during post-treatment follow-up phase.
|
240 mg Galcanezumab EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab or placebo. Participants did not receive any intervention during post-treatment follow-up phase.
|
120 mg Galcanezumab CM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. Participants did not receive any intervention during post-treatment follow-up phase.
|
240 mg Galcanezumab CM
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled. Participants did not receive any intervention during post-treatment follow-up phase.
|
|---|---|---|---|---|
|
Open Label
STARTED
|
120
|
126
|
32
|
33
|
|
Open Label
Received at Least 1 Dose of Study Drug
|
120
|
126
|
32
|
33
|
|
Open Label
120mg/120mg Galcanezumab - EM
|
58
|
0
|
0
|
0
|
|
Open Label
240mg/240mg Galcanezumab - EM
|
0
|
62
|
0
|
0
|
|
Open Label
Placebo/ 120mg Galcanezumab - EM
|
62
|
0
|
0
|
0
|
|
Open Label
Placebo/ 240mg Galcanezumab - EM
|
0
|
64
|
0
|
0
|
|
Open Label
COMPLETED
|
113
|
110
|
28
|
27
|
|
Open Label
NOT COMPLETED
|
7
|
16
|
4
|
6
|
|
Post Treatment Follow Up
STARTED
|
117
|
120
|
32
|
32
|
|
Post Treatment Follow Up
COMPLETED
|
114
|
119
|
31
|
32
|
|
Post Treatment Follow Up
NOT COMPLETED
|
3
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
120 mg Galcanezumab EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by subcutaneous (SC) injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab or placebo. Participants did not receive any intervention during post-treatment follow-up phase.
|
240 mg Galcanezumab EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab or placebo. Participants did not receive any intervention during post-treatment follow-up phase.
|
120 mg Galcanezumab CM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. Participants did not receive any intervention during post-treatment follow-up phase.
|
240 mg Galcanezumab CM
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled. Participants did not receive any intervention during post-treatment follow-up phase.
|
|---|---|---|---|---|
|
Open Label
Adverse Event
|
5
|
7
|
3
|
4
|
|
Open Label
Pregnancy
|
0
|
1
|
0
|
0
|
|
Open Label
Withdrawal by Subject
|
2
|
8
|
0
|
0
|
|
Open Label
Physician Decision
|
0
|
0
|
1
|
0
|
|
Open Label
Protocol Violation
|
0
|
0
|
0
|
2
|
|
Post Treatment Follow Up
Adverse Event
|
1
|
1
|
0
|
0
|
|
Post Treatment Follow Up
Withdrawal by Subject
|
2
|
0
|
1
|
0
|
Baseline Characteristics
A Study of LY2951742 (Galcanezumab) in Japanese Participants With Migraine
Baseline characteristics by cohort
| Measure |
120mg/120mg Galcanezumab - EM
n=58 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
|
240mg/240mg Galcanezumab - EM
n=62 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
|
Placebo/ 120mg Galcanezumab - EM
n=62 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
|
Placebo/ 240mg Galcanezumab - EM
n=64 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
|
120mg Galcanezumab - CM
n=32 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
|
240mg Galcanezumab - CM
n=33 Participants
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
|
Total
n=311 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.95 years
STANDARD_DEVIATION 10.04 • n=39 Participants
|
45.47 years
STANDARD_DEVIATION 9.79 • n=41 Participants
|
45.35 years
STANDARD_DEVIATION 10.69 • n=35 Participants
|
45.08 years
STANDARD_DEVIATION 8.88 • n=31 Participants
|
41.88 years
STANDARD_DEVIATION 9.40 • n=146 Participants
|
43.70 years
STANDARD_DEVIATION 11.53 • n=19 Participants
|
44.71 years
STANDARD_DEVIATION 9.98 • n=147 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=39 Participants
|
52 Participants
n=41 Participants
|
51 Participants
n=35 Participants
|
58 Participants
n=31 Participants
|
32 Participants
n=146 Participants
|
27 Participants
n=19 Participants
|
268 Participants
n=147 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
6 Participants
n=19 Participants
|
43 Participants
n=147 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=39 Participants
|
62 Participants
n=41 Participants
|
62 Participants
n=35 Participants
|
64 Participants
n=31 Participants
|
32 Participants
n=146 Participants
|
33 Participants
n=19 Participants
|
311 Participants
n=147 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Race (NIH/OMB)
Asian
|
58 Participants
n=39 Participants
|
62 Participants
n=41 Participants
|
62 Participants
n=35 Participants
|
64 Participants
n=31 Participants
|
32 Participants
n=146 Participants
|
33 Participants
n=19 Participants
|
311 Participants
n=147 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Region of Enrollment
Japan
|
58 Participants
n=39 Participants
|
62 Participants
n=41 Participants
|
62 Participants
n=35 Participants
|
64 Participants
n=31 Participants
|
32 Participants
n=146 Participants
|
33 Participants
n=19 Participants
|
311 Participants
n=147 Participants
|
PRIMARY outcome
Timeframe: Up To 16 MonthsPopulation: All participants who were randomized and received at least 1 dose of the study drug.
A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.
Outcome measures
| Measure |
120mg/120mg Galcanezumab - EM
n=58 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
|
240mg/240mg Galcanezumab - EM
n=62 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab..
|
Placebo/ 120mg Galcanezumab - EM
n=62 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
|
Placebo/ 240mg Galcanezumab - EM
n=64 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
|
120mg Galcanezumab - CM
n=32 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
|
240mg Galcanezumab - CM
n=33 Participants
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any TEAE
|
54 participants
|
56 participants
|
54 participants
|
61 participants
|
31 participants
|
29 participants
|
|
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any SAE
|
2 participants
|
0 participants
|
2 participants
|
2 participants
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Month 12: PredosePopulation: All participants who were randomized and received at least 1 dose of the study drug and had evaluable galcanezumab PK data.
Serum Concentration of Galcanezumab at month 12 is reported.
Outcome measures
| Measure |
120mg/120mg Galcanezumab - EM
n=56 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
|
240mg/240mg Galcanezumab - EM
n=53 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab..
|
Placebo/ 120mg Galcanezumab - EM
n=58 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
|
Placebo/ 240mg Galcanezumab - EM
n=57 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
|
120mg Galcanezumab - CM
n=28 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
|
240mg Galcanezumab - CM
n=27 Participants
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
|
21100 nanogram/milliliter (ng/mL)
Standard Deviation 6120
|
46000 nanogram/milliliter (ng/mL)
Standard Deviation 15300
|
21000 nanogram/milliliter (ng/mL)
Standard Deviation 7290
|
42200 nanogram/milliliter (ng/mL)
Standard Deviation 12400
|
20100 nanogram/milliliter (ng/mL)
Standard Deviation 8550
|
39600 nanogram/milliliter (ng/mL)
Standard Deviation 13600
|
SECONDARY outcome
Timeframe: Month 12: PredosePopulation: All participants who were randomized and received at least 1 dose of the study drug and had measurable CGRP concentrations.
Plasma Concentration of total CGRP at month 12 is reported.
Outcome measures
| Measure |
120mg/120mg Galcanezumab - EM
n=56 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
|
240mg/240mg Galcanezumab - EM
n=53 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab..
|
Placebo/ 120mg Galcanezumab - EM
n=58 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
|
Placebo/ 240mg Galcanezumab - EM
n=57 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
|
120mg Galcanezumab - CM
n=28 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
|
240mg Galcanezumab - CM
n=27 Participants
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
|
|---|---|---|---|---|---|---|
|
Pharmacodynamics (PD): Plasma Concentration of Total Calcitonin Gene-Related Peptide (CGRP)
|
4.51 ng/mL
Standard Deviation 1.26
|
5.87 ng/mL
Standard Deviation 1.45
|
4.69 ng/mL
Standard Deviation 1.45
|
5.59 ng/mL
Standard Deviation 1.45
|
4.37 ng/mL
Standard Deviation 1.40
|
5.19 ng/mL
Standard Deviation 1.52
|
SECONDARY outcome
Timeframe: Month 0, 1, 2, 3, 6, 9, 12 and 16: Predose; Month 0 and 14 days PostdosePopulation: All participants who were randomized and received at least 1 dose of the study drug and had evaluable immunogenicity data.
Treatment emergent ADA will be defined as any of the following: A negative baseline result and a positive post-baseline ADA result with a titer ≥20. This is also called treatment-induced ADA. A positive baseline result and a positive post-baseline ADA result with a ≥4-fold increase in titers (for example, baseline titer of 10 increasing to ≥40 post-baseline). This is called treatment-boosted ADA.
Outcome measures
| Measure |
120mg/120mg Galcanezumab - EM
n=58 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
|
240mg/240mg Galcanezumab - EM
n=62 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab..
|
Placebo/ 120mg Galcanezumab - EM
n=62 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
|
Placebo/ 240mg Galcanezumab - EM
n=64 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
|
120mg Galcanezumab - CM
n=32 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
|
240mg Galcanezumab - CM
n=33 Participants
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Developing Anti-Drug Antibodies (ADA)
|
12.07 percentage of participants
|
9.68 percentage of participants
|
16.13 percentage of participants
|
10.94 percentage of participants
|
12.50 percentage of participants
|
18.18 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Migraine Headache (EM Participants): A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B): A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia. Migraine Headache (CM Participants) : A headache, with or without aura, of greater than or equal to (≥30) minutes duration which meets criteria A and B or meets criterion C: A and B criteria as described above and criteria C) The headache is believed by the participant to be migraine at onset and is relieved by a triptan or ergot derivative.
Outcome measures
| Measure |
120mg/120mg Galcanezumab - EM
n=56 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
|
240mg/240mg Galcanezumab - EM
n=53 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab..
|
Placebo/ 120mg Galcanezumab - EM
n=58 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
|
Placebo/ 240mg Galcanezumab - EM
n=57 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
|
120mg Galcanezumab - CM
n=28 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
|
240mg Galcanezumab - CM
n=27 Participants
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in the Number of Migraine Headache Days (MHDs)
|
-1.82 MHDs
Standard Deviation 2.96
|
-1.49 MHDs
Standard Deviation 4.11
|
-4.29 MHDs
Standard Deviation 4.07
|
-3.23 MHDs
Standard Deviation 5.81
|
-9.44 MHDs
Standard Deviation 6.16
|
-8.97 MHDs
Standard Deviation 8.06
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
A headache day is calendar day on which any type of headache occurs,(including migraine headache, probable migraine headache, and non-migraine headache).
Outcome measures
| Measure |
120mg/120mg Galcanezumab - EM
n=56 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
|
240mg/240mg Galcanezumab - EM
n=53 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab..
|
Placebo/ 120mg Galcanezumab - EM
n=58 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
|
Placebo/ 240mg Galcanezumab - EM
n=57 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
|
120mg Galcanezumab - CM
n=28 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
|
240mg Galcanezumab - CM
n=27 Participants
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in the Number of Headache Days (HDs)
|
-2.37 Headache days (HDs)
Standard Deviation 3.62
|
-1.75 Headache days (HDs)
Standard Deviation 4.57
|
-5.04 Headache days (HDs)
Standard Deviation 4.71
|
-4.00 Headache days (HDs)
Standard Deviation 5.14
|
-9.30 Headache days (HDs)
Standard Deviation 6.83
|
-9.42 Headache days (HDs)
Standard Deviation 8.37
|
SECONDARY outcome
Timeframe: Month 12Population: All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. A 50% responder in a particular month is any participant who has a ≥50% reduction from baseline in the monthly number of migraine headache attacks in a 30-day interval.
Outcome measures
| Measure |
120mg/120mg Galcanezumab - EM
n=47 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
|
240mg/240mg Galcanezumab - EM
n=46 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab..
|
Placebo/ 120mg Galcanezumab - EM
n=55 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
|
Placebo/ 240mg Galcanezumab - EM
n=56 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
|
120mg Galcanezumab - CM
n=28 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
|
240mg Galcanezumab - CM
n=27 Participants
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Meeting Criteria for Reductions From Baseline Greater Than or Equal to (≥) 50% in Number of Migraine Headache Days
|
48.9 Percentage of participants
|
45.7 Percentage of participants
|
52.7 Percentage of participants
|
46.4 Percentage of participants
|
35.7 Percentage of participants
|
51.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
Migraine Headache Day (MHD) with Acute Medication Use: Calendar days on which migraine or probable migraine occurs, requiring acute medication.
Outcome measures
| Measure |
120mg/120mg Galcanezumab - EM
n=56 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
|
240mg/240mg Galcanezumab - EM
n=53 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab..
|
Placebo/ 120mg Galcanezumab - EM
n=58 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
|
Placebo/ 240mg Galcanezumab - EM
n=57 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
|
120mg Galcanezumab - CM
n=28 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
|
240mg Galcanezumab - CM
n=27 Participants
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine Headache
|
-1.40 MHDs with medication use
Standard Deviation 2.54
|
-1.00 MHDs with medication use
Standard Deviation 3.59
|
-3.87 MHDs with medication use
Standard Deviation 3.84
|
-3.01 MHDs with medication use
Standard Deviation 5.76
|
-8.36 MHDs with medication use
Standard Deviation 6.29
|
-7.43 MHDs with medication use
Standard Deviation 7.89
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
Monthly Migraine Headache Days or Headache Days Requiring Medication for the Acute Treatment of Migraine Headache or Headache: Calendar days on which headache, migraine or probable migraine occurs, requiring acute medication.
Outcome measures
| Measure |
120mg/120mg Galcanezumab - EM
n=56 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
|
240mg/240mg Galcanezumab - EM
n=53 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab..
|
Placebo/ 120mg Galcanezumab - EM
n=58 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
|
Placebo/ 240mg Galcanezumab - EM
n=57 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
|
120mg Galcanezumab - CM
n=28 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
|
240mg Galcanezumab - CM
n=27 Participants
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in the Number of Monthly Migraine Headache Days or Headache Days Requiring Medication for the Acute Treatment of Migraine Headache or Headache
|
-1.62 MHDs and HDs with medication use
Standard Deviation 3.21
|
-1.17 MHDs and HDs with medication use
Standard Deviation 3.89
|
-4.47 MHDs and HDs with medication use
Standard Deviation 4.81
|
-3.43 MHDs and HDs with medication use
Standard Deviation 5.53
|
-8.21 MHDs and HDs with medication use
Standard Deviation 6.84
|
-7.48 MHDs and HDs with medication use
Standard Deviation 8.21
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
The PGI-S scale is a patient-rated instrument that measures patients own global impression of their illness severity. The patient was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options were from 1 ("normal, not at all ill") to 7 ("extremely ill").
Outcome measures
| Measure |
120mg/120mg Galcanezumab - EM
n=56 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
|
240mg/240mg Galcanezumab - EM
n=53 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab..
|
Placebo/ 120mg Galcanezumab - EM
n=58 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
|
Placebo/ 240mg Galcanezumab - EM
n=57 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
|
120mg Galcanezumab - CM
n=28 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
|
240mg Galcanezumab - CM
n=27 Participants
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score
|
-0.29 score on a scale
Standard Deviation 0.76
|
-0.04 score on a scale
Standard Deviation 0.76
|
-0.02 score on a scale
Standard Deviation 0.66
|
0.11 score on a scale
Standard Deviation 0.77
|
-0.07 score on a scale
Standard Deviation 1.59
|
-0.81 score on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability.
Outcome measures
| Measure |
120mg/120mg Galcanezumab - EM
n=56 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
|
240mg/240mg Galcanezumab - EM
n=53 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab..
|
Placebo/ 120mg Galcanezumab - EM
n=58 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
|
Placebo/ 240mg Galcanezumab - EM
n=57 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
|
120mg Galcanezumab - CM
n=28 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
|
240mg Galcanezumab - CM
n=27 Participants
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
|
|---|---|---|---|---|---|---|
|
Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score
|
-0.38 score on a scale
Standard Deviation 8.99
|
-0.42 score on a scale
Standard Deviation 15.94
|
-8.67 score on a scale
Standard Deviation 17.39
|
-4.60 score on a scale
Standard Deviation 12.77
|
-20.71 score on a scale
Standard Deviation 32.66
|
-15.48 score on a scale
Standard Deviation 32.26
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
MSQ version 2.1 is a health status instrument,with a 4-week recall period,developed to address physical \& emotional limitations of specific concern to individuals with migraine.Addressing the impact of migraine on work or daily activities,relationships with family \& friends,leisure time,productivity,concentration, energy,tiredness \& feelings.It consists of 14 items addressing 3 domains:(1)Role Function-Restrictive (items 1-7);(2)Role Function- Preventive (items 8-11);\&(3)Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6), \& are reverse-recoded (value 6 to 1) before the domain scores are calculated.Total raw scores for each domain is the sum of the final item value for all of the items in that domain.After total raw score is computed for each domain \& total score, they are transformed to a 0-100 scale with higher scores indicating a better health status \& a positive change in scores reflecting functional improvement.
Outcome measures
| Measure |
120mg/120mg Galcanezumab - EM
n=56 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
|
240mg/240mg Galcanezumab - EM
n=53 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab..
|
Placebo/ 120mg Galcanezumab - EM
n=58 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
|
Placebo/ 240mg Galcanezumab - EM
n=57 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
|
120mg Galcanezumab - CM
n=28 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
|
240mg Galcanezumab - CM
n=27 Participants
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
|
|---|---|---|---|---|---|---|
|
Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1
Total Score
|
1.02 score on a scale
Standard Deviation 8.68
|
0.38 score on a scale
Standard Deviation 11.97
|
7.51 score on a scale
Standard Deviation 10.58
|
4.56 score on a scale
Standard Deviation 11.22
|
19.23 score on a scale
Standard Deviation 12.57
|
18.31 score on a scale
Standard Deviation 15.67
|
|
Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1
Role Function-Restrictive Domain
|
1.68 score on a scale
Standard Deviation 9.77
|
0.22 score on a scale
Standard Deviation 13.75
|
8.77 score on a scale
Standard Deviation 12.74
|
4.96 score on a scale
Standard Deviation 12.60
|
22.65 score on a scale
Standard Deviation 15.08
|
22.96 score on a scale
Standard Deviation 17.69
|
|
Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1
Role Function-Preventive Domain
|
0.09 score on a scale
Standard Deviation 9.70
|
0.75 score on a scale
Standard Deviation 13.17
|
7.16 score on a scale
Standard Deviation 10.18
|
3.77 score on a scale
Standard Deviation 12.86
|
15.89 score on a scale
Standard Deviation 13.68
|
13.52 score on a scale
Standard Deviation 16.63
|
|
Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1
Emotional Function Domain
|
0.71 score on a scale
Standard Deviation 10.54
|
0.25 score on a scale
Standard Deviation 11.47
|
5.06 score on a scale
Standard Deviation 11.47
|
4.68 score on a scale
Standard Deviation 12.34
|
15.71 score on a scale
Standard Deviation 13.96
|
13.83 score on a scale
Standard Deviation 17.82
|
SECONDARY outcome
Timeframe: Month 12Population: All participants who were randomized and received at least 1 dose of the study drug and had month 12 PSMQ-M measurement.
The PSMQ-M is a self-rated scale which measures participants level of satisfaction with study medication.The scale has been modified for use in this study, assessing 3 items related to the clinical trial treatment over the past 4 weeks: satisfaction, preference, and side effects.Satisfaction responses range from "very unsatisfied" to "very satisfied" with the current treatment (5 categories). Preference compared the current study medication to previous medications, with responses from "much rather prefer my previous medication" to "much rather prefer the medication administered to me during the study" (5 categories). The side effects responses range from "significantly less side effects" to "significantly more side effects" (5 categories). Positive responses for each item were defined as follows: Satisfaction: "Very Satisfied" or "Somewhat Satisfied"; Preference: "Much Prefer Study Medication" or "Prefer Study Medication"; Side Effects: "Much-Less Side Effects" or "Less Side Effects".
Outcome measures
| Measure |
120mg/120mg Galcanezumab - EM
n=56 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
|
240mg/240mg Galcanezumab - EM
n=53 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab..
|
Placebo/ 120mg Galcanezumab - EM
n=58 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
|
Placebo/ 240mg Galcanezumab - EM
n=57 Participants
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
|
120mg Galcanezumab - CM
n=28 Participants
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
|
240mg Galcanezumab - CM
n=27 Participants
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
Responder for satisfaction
|
80.4 Percentage of participants
|
73.6 Percentage of participants
|
72.4 Percentage of participants
|
73.7 Percentage of participants
|
82.1 Percentage of participants
|
74.1 Percentage of participants
|
|
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
Responder for preference
|
76.8 Percentage of participants
|
73.6 Percentage of participants
|
75.9 Percentage of participants
|
75.4 Percentage of participants
|
85.7 Percentage of participants
|
81.5 Percentage of participants
|
|
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
Responder for side effect
|
78.6 Percentage of participants
|
69.8 Percentage of participants
|
72.4 Percentage of participants
|
71.9 Percentage of participants
|
82.1 Percentage of participants
|
81.5 Percentage of participants
|
Adverse Events
120mg/120mg Galcanezumab - Open-Label Treatment Phase (Ph) -EM
Serious events: 2 serious events
Other events: 54 other events
Deaths: 0 deaths
240mg/240mg Galcanezumab - Open-Label Treatment Ph-EM
Serious events: 0 serious events
Other events: 56 other events
Deaths: 0 deaths
Placebo/ 120mg Galcanezumab - Open-Label Treatment - EM
Serious events: 2 serious events
Other events: 54 other events
Deaths: 0 deaths
Placebo/ 240mg Galcanezumab - Open-Label Treatment-EM
Serious events: 2 serious events
Other events: 61 other events
Deaths: 0 deaths
120mg Galcanezumab - Open-Label Treatment Phase-CM
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
240mg Galcanezumab - Open-Label Treatment Phase-CM
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
120mg Galcanezumab - Post-Treatment Phase - EM
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
240mg Galcanezumab - Post-Treatment Phase - EM
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
120mg Galcanezumab - Post-Treatment Phase - CM
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
240mg Galcanezumab - Post-Treatment Phase - CM
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
120mg/120mg Galcanezumab - Open-Label Treatment Phase (Ph) -EM
n=58 participants at risk
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
|
240mg/240mg Galcanezumab - Open-Label Treatment Ph-EM
n=62 participants at risk
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
|
Placebo/ 120mg Galcanezumab - Open-Label Treatment - EM
n=62 participants at risk
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
|
Placebo/ 240mg Galcanezumab - Open-Label Treatment-EM
n=64 participants at risk
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
|
120mg Galcanezumab - Open-Label Treatment Phase-CM
n=32 participants at risk
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
|
240mg Galcanezumab - Open-Label Treatment Phase-CM
n=33 participants at risk
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
|
120mg Galcanezumab - Post-Treatment Phase - EM
n=117 participants at risk
Participants didn't received any intervention
|
240mg Galcanezumab - Post-Treatment Phase - EM
n=120 participants at risk
Participants didn't received any intervention
|
120mg Galcanezumab - Post-Treatment Phase - CM
n=32 participants at risk
Participants didn't received any intervention
|
240mg Galcanezumab - Post-Treatment Phase - CM
n=32 participants at risk
Participants didn't received any intervention
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/48 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/96 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Fracture malunion
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Uterine polyp
|
2.1%
1/48 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/96 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Other adverse events
| Measure |
120mg/120mg Galcanezumab - Open-Label Treatment Phase (Ph) -EM
n=58 participants at risk
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
|
240mg/240mg Galcanezumab - Open-Label Treatment Ph-EM
n=62 participants at risk
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
|
Placebo/ 120mg Galcanezumab - Open-Label Treatment - EM
n=62 participants at risk
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
|
Placebo/ 240mg Galcanezumab - Open-Label Treatment-EM
n=64 participants at risk
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
|
120mg Galcanezumab - Open-Label Treatment Phase-CM
n=32 participants at risk
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
|
240mg Galcanezumab - Open-Label Treatment Phase-CM
n=33 participants at risk
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
|
120mg Galcanezumab - Post-Treatment Phase - EM
n=117 participants at risk
Participants didn't received any intervention
|
240mg Galcanezumab - Post-Treatment Phase - EM
n=120 participants at risk
Participants didn't received any intervention
|
120mg Galcanezumab - Post-Treatment Phase - CM
n=32 participants at risk
Participants didn't received any intervention
|
240mg Galcanezumab - Post-Treatment Phase - CM
n=32 participants at risk
Participants didn't received any intervention
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
4.2%
2/48 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/96 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
3.4%
2/58 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.7%
3/64 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Migraine
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Occipital neuralgia
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
5.2%
3/58 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Thunderclap headache
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/48 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/96 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety disorder
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Frustration tolerance decreased
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Stress
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Adenomyosis
|
2.1%
1/48 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/96 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
2.1%
1/48 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/96 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/48 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/96 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.1%
1/48 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
1/96 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Endometriosis
|
2.1%
1/48 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/96 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Skin cyst excision
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Menopausal disorder
|
0.00%
0/48 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/96 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Tendon sheath incision
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.1%
2/33 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Deafness transitory
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Meniere's disease
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Endocrine disorders
Thyroid cyst
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Asthenopia
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Blepharitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
2/117 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Conjunctival haemorrhage
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
3/62 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Conjunctivitis allergic
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
4/64 • Number of events 5 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Dry eye
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Keratitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 4 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.7%
3/64 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.4%
2/58 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.4%
6/64 • Number of events 6 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Chapped lips
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Cheilitis
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Chronic gastritis
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
8.6%
5/58 • Number of events 6 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
3/62 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dental caries
|
5.2%
3/58 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
3/62 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.3%
7/62 • Number of events 7 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.8%
5/64 • Number of events 5 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.1%
2/33 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
2/117 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dental cyst
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
3/62 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
4/32 • Number of events 4 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
3/62 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Hyperaesthesia teeth
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestine polyp
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Lip erosion
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oesophageal discomfort
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Periodontal disease
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Stomatitis
|
3.4%
2/58 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Toothache
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
3/62 • Number of events 4 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
2/64 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Asthenia
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Chest pain
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Chills
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Discomfort
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Fatigue
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Feeling abnormal
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Hangover
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 5 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site bruising
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site eczema
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site erythema
|
19.0%
11/58 • Number of events 37 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
24.2%
15/62 • Number of events 66 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
17.7%
11/62 • Number of events 53 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
25.0%
16/64 • Number of events 50 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.4%
3/32 • Number of events 4 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.1%
3/33 • Number of events 15 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site hypoaesthesia
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site induration
|
5.2%
3/58 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 6 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.9%
7/64 • Number of events 10 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site inflammation
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site mass
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
2/64 • Number of events 7 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site pain
|
1.7%
1/58 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
3/62 • Number of events 7 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
4/62 • Number of events 5 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
17.2%
11/64 • Number of events 31 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.1%
3/33 • Number of events 6 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site pruritus
|
12.1%
7/58 • Number of events 26 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
14.5%
9/62 • Number of events 22 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.1%
10/62 • Number of events 33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
26.6%
17/64 • Number of events 68 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
15.6%
5/32 • Number of events 9 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.1%
4/33 • Number of events 18 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site rash
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.7%
3/64 • Number of events 13 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 5 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site reaction
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site swelling
|
10.3%
6/58 • Number of events 17 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.1%
5/62 • Number of events 12 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
4/62 • Number of events 12 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.9%
7/64 • Number of events 17 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site urticaria
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site warmth
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injury associated with device
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Malaise
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.1%
2/33 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Oedema
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 5 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
2/120 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Swelling
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Thirst
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Seasonal allergy
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Adenoviral conjunctivitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Chronic sinusitis
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis
|
3.4%
2/58 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cystitis
|
3.4%
2/58 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
4/64 • Number of events 6 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.1%
4/33 • Number of events 5 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cystitis bacterial
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Dermatophytosis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Folliculitis
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
6.9%
4/58 • Number of events 4 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.1%
5/62 • Number of events 6 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis norovirus
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gingivitis
|
6.9%
4/58 • Number of events 4 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Helicobacter infection
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Herpes dermatitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
2/117 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
8.6%
5/58 • Number of events 5 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
17.7%
11/62 • Number of events 11 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.9%
8/62 • Number of events 8 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.8%
5/64 • Number of events 5 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
4/32 • Number of events 4 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.1%
2/33 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
2/120 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
46.6%
27/58 • Number of events 44 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
46.8%
29/62 • Number of events 45 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
40.3%
25/62 • Number of events 44 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
50.0%
32/64 • Number of events 48 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
40.6%
13/32 • Number of events 19 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
48.5%
16/33 • Number of events 23 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
9/117 • Number of events 10 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
8/120 • Number of events 8 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Oral herpes
|
3.4%
2/58 • Number of events 4 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.1%
2/33 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Otitis media
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/48 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/96 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.1%
2/33 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis
|
3.4%
2/58 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
2/117 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pyelitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Rhinitis
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
3.4%
2/58 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
2/120 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Vaginal infection
|
2.1%
1/48 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/96 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Viral tonsillitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/48 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
1/96 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
3.4%
2/58 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Bite
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Heat illness
|
3.4%
2/58 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Injury
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
3.4%
2/58 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Tooth injury
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Wound
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.7%
3/64 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Anti-cyclic citrullinated peptide antibody positive
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Heart rate increased
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Liver function test increased
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Platelet count increased
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Urine ketone body present
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
2/58 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.7%
6/62 • Number of events 6 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
4/64 • Number of events 5 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.1%
2/33 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
2/120 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Fracture malunion
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Nodal osteoarthritis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
2.1%
1/48 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/96 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/48 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/96 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/48 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/96 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
2.1%
1/48 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.4%
2/58 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/96 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic bronchitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.7%
3/64 • Number of events 4 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.1%
3/33 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Choking sensation
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
2/64 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Cold urticaria
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.4%
2/58 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.7%
3/64 • Number of events 4 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Erythema annulare
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Nail bed bleeding
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
1.7%
1/58 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.7%
1/58 • Number of events 5 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
4/62 • Number of events 4 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
3/62 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.4%
3/32 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
3/120 • Number of events 3 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria chronic
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria thermal
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Appendicectomy
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
1/33 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Bone graft
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Cervical polypectomy
|
0.00%
0/48 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/27 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/96 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Endodontic procedure
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Haemorrhoid operation
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Intervertebral disc operation
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Ligament operation
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Lipectomy
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Mastectomy
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Polypectomy
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Removal of foreign body
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.83%
1/120 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Sinus operation
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Wisdom teeth removal
|
1.7%
1/58 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/117 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
0.00%
0/58 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.85%
1/117 • Number of events 1 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/120 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Up To 16 Months
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review the study result with PIs prior to public release and can embargo a communication about it until the public release by the contract with Investigator sites.
- Publication restrictions are in place
Restriction type: OTHER